R E 1 Assessment of environmental risks of biocides - focus on emission scenarios EU course on Environmental Exposure Scenarios in Risk Assessment

Assessment of environmental risks of biocides - focus on emission scenarios

EU course on Environmental Exposure Scenarios in Risk Assessment

2Environmental risks of biocides | Peter van der Zandt & Paul van der Poel

EU Regulations and Directives

new chemicals EC Directive 67/548/EEC

existing chemicals EC Council Reg. 793/93

pesticides EC Directives 91/414/EEC

biocides EC Directive 98/8/EEC

veterinary drugs EC Regulation 2377/90

feed additives EC Directive 70/524/EEC

food additives 89/107/EEC

cosmetics SCP/803/90

packaging material EC Directive CS/PM/1025


Elements of ‘Chemicals Control’

• Data collection and exchange of information • Classification and labelling

• Risk assessment

• Risk management (a.o. authorisation)


The EU Biocidal Products Directive (1998) Why ? : Risk Management !

Whereas 1: ‘.. 1993 .. Council .. need for risk management of non-agricultural pesticides ..’

How ? (1): Authorisation procedureWhereas 4: ‘.. rules for placing on the market .. taking as a condition a high level of protection for humans, animals and the environment ..’

How ? (2): Risk AssessmentWhereas 7, 8, 9, 11; Article 5; Annex VITGDs: data requirements, risk assessment of active substances, ...


Environmental Risk Assessment: Basic Framework

PEC/PNEC

Risk characterization

Data set

Data evaluation

Single speciestoxicity data

Extrapolation

PNEC

Effects assessment

Emissions

Distribution

PEC

Exposure assessment

EUSES

TGD


Life cycle Life cycle PRODUCTION

FORMULATION

SERVICE LIFE

PRIVATE USE INDUSTRIALUSE

In product In product Processingaid

WASTE DISPOSAL - Incineration - Landfilling - Recovery

Processingaid


STP

GrasslandAgricultural

soil

Surfacewater

Sediment

Groundwater

AirDeposition

Leaching

Sedimentation

Dilution

Sludge applicationV

ola

tiliz

atio

nLocal emissions

Local emission and distribution routes


Indicative food chains

fish

PREDATORS SOILPOREWATER

SURFACEWATER

earthworm


Exposure assessment (results)

Protection target PEC

__________________________________________

micro-organisms STP effluent

aquatic organisms surface water

terrestrial organisms agricultural soil

sediment organisms sediment

predators fish or earthworms

__________________________________________


Effects assessment

• laboratory testing (single species; standardised test)

• various trophic levels

algae

+ +

crustacea fish

Aquatic ecosystem ?


PNEC derivation (water)

Data Assessment factor

Short-term L(E)C50 from each of three trophic levels of 1000the base-set (fish, daphnia, algae)

One long-term NOEC (either fish or Daphnia) 100

Two long-term NOECs from species representing two 50trophic levels (fish and/or Daphnia and/or algae)

Long-term NOECs from at least three species representing 10three trophic levels (normally fish, Dapnia, algae)

Field data or model ecosystems case by case


EU TGD: importance of emission estimation

• The TGDs were to be revised, and to also incorporate aspects which are specific for risk assessment of biocides

• For biocides, the addition of specific emission and exposure scenarios had a high priority (Biocides TM, 1999)

why ?– uses are the most prominent difference with other

chemicals– emission has most significant influence on the final

outcome of risk assessment


Experience of initial vs. refined RAs

Uncertainty Factor__________________________________________

PNEC ± 10emission rates 10 - > 1000STP emission estimation < 10biodegradation in surface water < 10exposure assessment PEC 10 - > 10,000__________________________________________


EEmmiissssiioonnSSccee aarrii ssoonn


Definition of ESD

• An Environmental Emission Scenario Document is:

“A set of conditions about sources, pathways, production processes and use patterns that quantify the emissions (or releases) of a chemical from production, formulation, processing, private use (or use in the household) and recovery/disposal into water, air and solid waste”

(OECD 2000)

• In general, an ESD should cover all aspects of the life-cycle. An ESD may cover only some parts of the life-cycle, if remaining parts are not relevant or covered by another ESD.


Life Cycle & Risk AssessmentLife Cycle & Risk Assessment

PRODUCTION

FORMULATION

APPLICATION

SERVICE LIFE

WASTE

New &ExistingSubstances

BiocidalProductsDirective

Local &Local &RegionalRegionalScaleScale

LocalLocalScaleScale


Local scale Local scale (1 point source(1 point sourcefor each life for each life cycle stage)cycle stage)

ProcessNext stageNext stageof life cycleof life cycle

AIRAIR100 m100 m

WastewaterWastewaterSTPSTP

SOILSOIL


PP

PP

FFFF FF

IIIIII IIII

II

II

II

IIII

II IIII

II

Regional scaleRegional scale(all sources(all sources all stages of l.c.)all stages of l.c.)

Production Production FormulationFormulation Industrial useIndustrial use


ProcessProcess

• Quantity of productQuantity of product

• Content in productContent in product

• Emission factor(s)Emission factor(s)

• Industrial categoryIndustrial category

• Function of substancesFunction of substances

Factors of ImportanceFactors of Importance


Concept of Emission EstimationConcept of Emission Estimation

ElementsElements::• Description of the industry or use area (‘process’)Description of the industry or use area (‘process’)• Description of the types of substances used and their Description of the types of substances used and their

function in the industry areafunction in the industry area• Identification of points of release and emission Identification of points of release and emission

factorsfactors• Information on the scale/size of operationsInformation on the scale/size of operations• Information on emission control measuresInformation on emission control measures• Instruction on how to use the information in ESD Instruction on how to use the information in ESD

and examples of calculationsand examples of calculations


Emission = Q * Fms * EF / Tem * 10Emission = Q * Fms * EF / Tem * 10-3 -3 (kg.d(kg.d-1-1))

Emission Scenario 1: Tonnage of SubstanceEmission Scenario 1: Tonnage of Substance

EFEF Emission factor (-)Emission factor (-) TemTem Number of emission days (d.yrNumber of emission days (d.yr-1-1))

Main SourceMain Source

TonnageTonnage

WaterWater AirAir

SoilSoil WasteWasteEmissionEmissionfactorsfactors

No. of daysNo. of days

INPUTINPUT:: QQ Tonnage (tonnes.yrTonnage (tonnes.yr-1-1)) FmsFms Fraction of the main source (-)Fraction of the main source (-)


Emission = Qp * Qs * EF Emission = Qp * Qs * EF (kg.d(kg.d-1-1))

Emission Scenario 2: Scale of ProcessEmission Scenario 2: Scale of Process

INPUTINPUT:: QpQp Tonnage of product (tonnes.dTonnage of product (tonnes.d-1-1)) QsQs Quantity of substance (kg.tonneQuantity of substance (kg.tonne-1-1 product) product) EFEF Emission factor (-)Emission factor (-)

Emission FactorEmission Factor


Emission Scenario 3: Average consumptionEmission Scenario 3: Average consumption

Emission = Qi * Ni * Fpc * Cs * EF Emission = Qi * Ni * Fpc * Cs * EF (kg.d(kg.d-1-1))

INPUTINPUT:: QiQi Consumption per inhabitant (l.dConsumption per inhabitant (l.d-1-1)) CsCs Content of the substance in product (kg.lContent of the substance in product (kg.l-1-1) ) FpcFpc Fraction of product with substance (-) Fraction of product with substance (-) EFEF Emission factor (-)Emission factor (-) NiNi Number of inhabitants (-)Number of inhabitants (-)


New & Existing substances Biocides New & Existing substances Biocides

A Biocide is a new or existing substanceA Biocide is a new or existing substance butbut

a new or existing substance is not (always) a biocidea new or existing substance is not (always) a biocide

A Biocide has a specific function : A Biocide has a specific function : • DisinfectantDisinfectant• PreservativePreservative• Insecticide, acaricide, avicide, piscicide, . . . Insecticide, acaricide, avicide, piscicide, . . .


Biocidal Products Directive 98/8/EGBiocidal Products Directive 98/8/EGAnnex VAnnex V23 biocidal product types23 biocidal product types

Biocides Biocides (Use Category 39)(Use Category 39)


EU Biocidal Products DirectiveEU Biocidal Products Directive

23 Product Types divided over 4 Groups:23 Product Types divided over 4 Groups:

I I DISINFECTANTS & GENERAL BIOCIDESDISINFECTANTS & GENERAL BIOCIDES

IIII PRESERVATIVESPRESERVATIVES

IIIIII PEST CONTROL PRODUCTSPEST CONTROL PRODUCTS

IVIV OTHER BIOCIDESOTHER BIOCIDES


11 Human hygiene biocidal productsHuman hygiene biocidal products

22 Private & public-health area disinfectantsPrivate & public-health area disinfectants

and other biocidal productsand other biocidal products

33 Veterinary hygiene biocidal productsVeterinary hygiene biocidal products

44 Food and feeding area disinfectantsFood and feeding area disinfectants

55 Drinking water disinfectantsDrinking water disinfectants

I I DISINFECTANTS & GENERAL BIOCIDESDISINFECTANTS & GENERAL BIOCIDES


66 In-can preservativesIn-can preservatives77 Film preservativesFilm preservatives88 Wood preservativesWood preservatives99 Fibre, leather, rubber and polymerised Fibre, leather, rubber and polymerised

materials preservativesmaterials preservatives1010 Masonry preservativesMasonry preservatives1111 Preservatives for liquid cooling and Preservatives for liquid cooling and

processing systemsprocessing systems1212 SlimicidesSlimicides1313 Metalworking-fluid preservativesMetalworking-fluid preservatives

IIII PRESERVATIVESPRESERVATIVES


1414 RodenticidesRodenticides

1515 AvicidesAvicides

1616 MolluscicidesMolluscicides

1717 PiscicidesPiscicides

1818 Insecticides, acaricides & products to Insecticides, acaricides & products to

control other arthropod speciescontrol other arthropod species

1919 Repellents and attractantsRepellents and attractants

IIIIII PEST CONTROL PRODUCTSPEST CONTROL PRODUCTS


20 Preservatives for food or feedstocks20 Preservatives for food or feedstocks

2121 Antifouling productsAntifouling products

2222 Embalming and taxidermist fluidsEmbalming and taxidermist fluids

IVIV OTHER BIOCIDESOTHER BIOCIDES

2323 Control of other vertabratesControl of other vertabrates


Example 1 Example 1

Pt 1 : Human Hygiene Biocidal ProductsPt 1 : Human Hygiene Biocidal Products

PRODUCTION

FORMULATION

PRIVATE USE

SERVICE LIFE

WASTE

For example:For example:

• Deodorants, antiperspirantsDeodorants, antiperspirants

• Anti-dandruff shampooAnti-dandruff shampoo

• Antimicrobial soapAntimicrobial soap

Etc.Etc.

• Skin application Skin application

• Short Short term term

• BathingBathing


Example 1 Pt 1 : Human Hygiene Biocidal ProductsExample 1 Pt 1 : Human Hygiene Biocidal Products

Emission Scenarios of New & Existing SubstancesEmission Scenarios of New & Existing Substances

a) Tonnagea) Tonnage

b) Average consumption per inhabitantb) Average consumption per inhabitant


Example 2 Example 2

Pt 3 : Veterinary Hygiene Biocidal ProductsPt 3 : Veterinary Hygiene Biocidal Products

3.13.1 Disinfection of animal housingDisinfection of animal housing

3.23.2 Disinfection of footwear and animals’feetDisinfection of footwear and animals’feet

3.33.3 Disinfection of Disinfection of milk extraction systemsmilk extraction systems

3.43.4 Disinfection of Disinfection of means of transportmeans of transport

3.53.5 Disinfection of hatcheriesDisinfection of hatcheries

3.63.6 Disinfection of fishfarmsDisinfection of fishfarms


PRODUCTION

FORMULATION

APPLICATION

SERVICE LIFE

WASTE

Example 2 Disinfection of animal housingExample 2 Disinfection of animal housing

“ ”

“ ”


Moment of Moment of manuringmanuring

Example 2 Disinfection of animal housingExample 2 Disinfection of animal housing

No. of cows No. of cows

Time Time

Maximum per haMaximum per ha

N / PN / P22OO55


The EUBEES projects

• In 1999, a number of EU Member States, the

European Chemicals Bureau and the European

chemical industry (CEFIC), and supported by the

European Commission, set up the EUBEES

working group to develop environmental emission

scenarios for environmental risk assessment of

biocides in the framework of the Biocidal Products

Directive.

EUBEES

• EUBEES 1 project: January 2000 until June 2001• EUBEES 2 project: January 2002 until November 2003


EUBEES 1: Results (1)

• Report ‘Development of emission scenario documents for 23

product groups of the EU biocidal products directive 98/8/EG’,

INFU/UBA, D.

• ‘Emission scenario document for product type 2: private and

public health area disinfectants and other biocidal products

(sanitary and medical sector)’, RIVM, NL.

• ‘Emission scenario document for biocides used in paper coating

and finishing (product type 6,7&9)’, INERIS, F.

• ‘Emission scenario document for biocides used as preservatives

in the leather industry (product type 9)’, INERIS, F.


EUBEES 1: Results (2)

• ‘Emission scenario document for biocides used as preservatives

in the textile processing industry (product type 9&18)’, INERIS, F.

• ‘Emission scenario document for biocides used in taxidermist and

embalming processes (product type 22)’, INERIS, F.

• Report ‘Proposal for the formats of names, parameters, variables,

units and symbols to be used in emission scenario documents’ ,

RIVM, NL.


EUBEES 2: objectives and results (1)

1 Development of harmonised ESDs:

PT 11: preservatives liquid cooling & processing

PT 12: slimicides

PT 13: metal working fluid preservatives

[PT 21: antifouling products (in OECD)]

2 Check ESDs for existing substances on their suitability for

biocides:

PT 1: human hygiene biocidal products

PT 6: in-can preservatives

PT 7: film preservatives

PT 9: fibre, leather, rubber, polymerised material pres.


EUBEES 2: objectives and results (2)

3 Provide a framework for EU discussion and agreement of new

ESDs developed by the members, eg.:

PT 5: drinking water disinfectants

PT 10: masonry preservatives

PT 14: rodenticides

PT 18: insecticides (in stables and manure)

4 Test the scenarios for wood preservatives developed by OECD

and rodenticides developed by the Nordics in the framework of

EUBEES, primarily with regard to usability.


OECD ESD on antifouling products

• Antifoulants: inhibit growth of organisms on ship hulls, fishing nets, marine structures. (several definitions!)

• Aim: OECD-wide harmonisation of available emission scenarios for anti-fouling applications.

• Most antifoulings, ie. 95% are used on ship hulls. Almost all available scenarios deal with the estimation of releases of antifoulings during the service life.

• The EESAF steering group will have its third meeting in November 2003. The draft ESD is intended to be finalised early 2004 and submitted to the OECD JM end 2004.


ESDs for Main Group 1 (disinfectants)

• PT 01: Human hygiene biocidal products (RIVM, EUBEES2)

• PT 02: Private and public health area disinfectants– Medical equipment (EU)

– Accomodation (RIVM)

– Industrial areas – Swimming pools (RIVM)

– Air-conditioning – Chemical toilets – Wastewater treatment (RIVM)

– Hospital waste


ESDs for Main Group 1 (disinfectants)

• PT 03: Veterinary hygiene biocidal products () (RIVM)

• PT 04: Food and feed area disinfectants

• PT 05: Drinking water disinfectants ( )

(UBA EUBEES 2 CA)

EUBEES


ESDs for Main Group 2 (preservatives)

• PT 07: Film preservatives– Paints & coatings (PT 06) – Plastics (PT 09) – Glues & adhesives (RIVM)– Paper & cardboard (RIVM)

• PT 08: Wood preservatives (OECD)



• PT 09: Fibre, leather, rubber & polymer pres.– Textiles & fabrics (EU)– Leather & hides (EU)– Paper & cardboard (EU)– Rubber, polymers, etc.

• PT 10: Masonry preservatives () (EUBEES 2 CA)



• PT 11: Preservatives for liquid cooling & processing systems– Cooling systems () (EUBEES 2 CA)– Processing water & liquids

• PT 12: Slimicides– Paper & pulp () (EUBEES 2 TM)– Mineral oil extraction () (EUBEES 2 TM)

• PT 13: Metalworking-fluid preservatives () (EUBEES 2 CA)


ESDs for Main Group 3 (pest control)

• PT 14: Rodenticides () (DK EUBEES 2 CA)

• PT 15: Avicides () (F EUBEES 2 TM)

• PT 16: Molluscicides

• PT 17: Piscicides

E = c pond


ESDs for Main Group 3 (pest control)

• PT 18: Insecticides, acaricides and products to control other arthropods– Manure & stables () (RIVM)– Refuse dumps – Fumigants (RIVM)

• PT 19: Repellents and attractants


ESDs for Main Group 4 (other products)

• PT 20: Preservatives for food & feedstocks

• PT 21: Antifouling products () ongoing

• PT 22: Embalming and taxidermist fluids (EU)• PT 23: Control of other vertebrates


EU Risk Assessment TGD new version

• Harmonised Approach to Risk Assessment of

New Chem, Existing Chem and Biocides

• Harmonised Approach to Risk Assessment in the

Marine Environment (N.E.B. and OSPAR)

• Include in Guidance what has been learned in the

Existing and New Chemicals areas

• Include specific guidance for Biocides

(i.e. emission scenarios!)

• Reducing discussion time and disagreements

through increasing the extent of guidance

http://ecb.jrc.it > documents


Revised TGD (2003): relevant exposure assessment issues

• More complete life cycle assessment

• Release estimation – emissions from long-life articles– emissions from waste disposal including recovery

• Unintentional uses: calculation of background concentrations


Nice questions! (1)

• Should the waste stage be included in the exposure assessment of biocides?

• Yes, the BPD in principle covers also waste stage

• However the TGD (2003) and the OECD PT8 ESD do not contain models to quantify emissions from waste stage. Relevant assumptions would include (wood preservatives):– how much wood enters the waste stage– how much of that goes to landfill, resp. incineration– how much of the a.i. is still left in the wood– etc..


Nice questions! (2)

• How to use the new (TGD) long-life article emission scenario for wood preservatives and what is the relation to the OECD wood in service scenario?

• The TGD approach deals with constant emissions over a long time and relates to the regional scale.

• The OECD scenarios should be followed for wood preservatives. The scenario for wood in service has a different approach. The TGD scenario does not apply for wood preservatives.


Nice questions! (3)

• How should background concentrations and PEC regional be calculated for biocides? Which releases should be taken into account?

• Biocides emissions generally pertain to local emissions and result in calculations of PEC local.

• Background concentrations and PEC regional can therefore normally not be determined.

Documents

R E 1 Assessment of environmental risks of biocides - focus on emission scenarios EU course on Environmental Exposure Scenarios in Risk Assessment