EU course on Environmental Exposure Scenarios in Risk Assessment
Assessment of environmental
risks of biocides focus on emission scenarios
ER
1
EU Regulations and Directives
new chemicals
existing chemicals
pesticides
biocides
veterinary drugs
feed additives
food additives
cosmetics
packaging material
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EC Directive 67/548/EEC
EC Council Reg. 793/93
EC Directives 91/414/EEC
EC Directive 98/8/EEC
EC Regulation 2377/90
EC Directive 70/524/EEC
89/107/EEC
SCP/803/90
EC Directive CS/PM/1025
Environmental risks of biocides | Peter van der Zandt & Paul van der Poel
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Elements of ‘Chemicals Control’
• Data collection and exchange of information
• Classification and labelling
• Risk assessment
• Risk management (a.o. authorisation)
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Environmental risks of biocides | Peter van der Zandt & Paul van der Poel
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The EU Biocidal Products Directive (1998)
 Why ? :
Risk Management !
Whereas 1: ‘.. 1993 .. Council .. need for risk management of nonagricultural pesticides ..’
 How ? (1):
Authorisation procedure
Whereas 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 Assessment
Whereas 7, 8, 9, 11; Article 5; Annex VI
TGDs: data requirements, risk assessment of active substances, ...
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Environmental risks of biocides | Peter van der Zandt & Paul van der Poel
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Environmental Risk Assessment:
Basic Framework
Data evaluation
Exposure assessment
Data set
Effects assessment
Emissions
TGD
Single species
toxicity data
Distribution
EUSES
Extrapolation
PNEC
PEC
Risk characterization
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PEC/PNEC
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PRODUCTION
Life cycle
FORMULATION
INDUSTRIAL
USE
PRIVATE USE
Processing
In product
aid
In product
Processing
aid
SERVICE LIFE
WASTE DISPOSAL
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- Incineration
- Landfilling
- Recovery
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Local emission and distribution routes
Air
Deposition
Local emissions
Grassland
Agricultural
soil
Leaching
Groundwater
STP
Dilution
Surface
water
Sedimentation
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Sediment
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Indicative food chains
PREDATORS
SOIL
POREWATER
earthworm
SURFACE
WATER
fish
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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
__________________________________________
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Effects assessment
• laboratory testing (single species; standardised test)
• various trophic levels
+
algae
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+
crustacea
fish
Aquatic ecosystem ?
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PNEC derivation (water)
Data
Assessment factor
Short-term L(E)C50 from each of three trophic levels of
the base-set (fish, daphnia, algae)
1000
One long-term NOEC (either fish or Daphnia)
100
Two long-term NOECs from species representing two
trophic levels (fish and/or Daphnia and/or algae)
50
Long-term NOECs from at least three species representing
three trophic levels (normally fish, Dapnia, algae)
10
Field data or model ecosystems
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case by case
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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
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Experience of initial vs. refined RAs
Uncertainty
Factor
__________________________________________
PNEC
± 10
emission rates
10 - > 1000
STP emission estimation
< 10
biodegradation in surface water
< 10
exposure assessment PEC
10 - > 10,000
__________________________________________
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Emission
Sce n ari o s
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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.
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Life Cycle & Risk Assessment
New &
Existing
Substances
PRODUCTION
FORMULATION
APPLICATION
Local &
Regional
Scale
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Biocidal
Products
Directive
SERVICE LIFE
WASTE
Local
Scale
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Local scale
(1 point source
for each life
cycle stage)
Next stage
of life cycle
AIR
100 m
Process
Wastewater
STP
SOIL
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Regional scale
(all sources
all stages of l.c.)
I
I
II
I
Production
PFI I I
Formulation
F
Industrial use
I
I
I
I
F I
I
P
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Factors of Importance
Process
• Industrial category
• Function of substances
• Quantity of product
• Content in product
• Emission factor(s)
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Concept of Emission Estimation
Elements:
• Description of the industry or use area (‘process’)
• Description of the types of substances used and their
function in the industry area
• Identification of points of release and emission
factors
• Information on the scale/size of operations
• Information on emission control measures
• Instruction on how to use the information in ESD
and examples of calculations
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Emission Scenario 1: Tonnage of Substance
INPUT:
Q
Tonnage (tonnes.yr-1)
Fms Fraction of the main source (-)
EF
Emission factor (-)
Tem Number of emission days (d.yr-1)
Emission = Q * Fms * EF / Tem * 10-3 (kg.d-1)
Main Source
No. of days
Water
Tonnage
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Emission
factors
Soil
Environmental risks of biocides | Peter van der Zandt & Paul van der Poel
Air
Waste
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Emission Scenario 2: Scale of Process
INPUT:
Qp
Tonnage of product (tonnes.d-1)
Qs
Quantity of substance (kg.tonne-1 product)
EF
Emission factor (-)
Emission = Qp * Qs * EF (kg.d-1)
Emission Factor
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Emission Scenario 3: Average consumption
INPUT:
Qi
Consumption per inhabitant (l.d-1)
Cs
Content of the substance in product (kg.l-1)
Fpc Fraction of product with substance (-)
EF
Emission factor (-)
Ni
Number of inhabitants (-)
Emission = Qi * Ni * Fpc * Cs * EF (kg.d-1)
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New & Existing substances
Biocides
A Biocide is a new or existing substance
but
a new or existing substance is not (always) a biocide
A Biocide has a specific function :
• Disinfectant
• Preservative
• Insecticide, acaricide, avicide, piscicide, . . .
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Biocides (Use Category 39)
Biocidal Products Directive 98/8/EG
Annex V
23 biocidal product types
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EU Biocidal Products Directive
23 Product Types divided over 4 Groups:
I
DISINFECTANTS & GENERAL BIOCIDES
II PRESERVATIVES
III PEST CONTROL PRODUCTS
IV OTHER BIOCIDES
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I DISINFECTANTS & GENERAL BIOCIDES
1 Human hygiene biocidal products
2 Private & public-health area disinfectants
and other biocidal products
3 Veterinary hygiene biocidal products
4 Food and feeding area disinfectants
5 Drinking water disinfectants
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II
6
7
8
9
10
11
12
13
PRESERVATIVES
In-can preservatives
Film preservatives
Wood preservatives
Fibre, leather, rubber and polymerised
materials preservatives
Masonry preservatives
Preservatives for liquid cooling and
processing systems
Slimicides
Metalworking-fluid preservatives
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III
PEST CONTROL PRODUCTS
14
15
16
17
18
Rodenticides
Avicides
Molluscicides
Piscicides
Insecticides, acaricides & products to
control other arthropod species
19 Repellents and attractants
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IV
OTHER BIOCIDES
20 Preservatives for food or feedstocks
21 Antifouling products
22 Embalming and taxidermist fluids
23 Control of other vertabrates
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Example 1
Pt 1 : Human Hygiene Biocidal Products
PRODUCTION
For example:
FORMULATION
• Deodorants, antiperspirants
• Anti-dandruff shampoo
• Skin application
• Antimicrobial soap
Etc.
• Short
term
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• Bathing
PRIVATE USE
SERVICE LIFE
WASTE
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Example 1 Pt 1 : Human Hygiene Biocidal Products
Emission Scenarios of New & Existing Substances
a) Tonnage
b) Average consumption per inhabitant
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Example 2
Pt 3 : Veterinary Hygiene Biocidal Products
3.1
3.2
3.3
3.4
3.5
3.6
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Disinfection of animal housing
Disinfection of footwear and animals’feet
Disinfection of milk extraction systems
Disinfection of means of transport
Disinfection of hatcheries
Disinfection of fishfarms
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Example 2 Disinfection of animal housing
PRODUCTION
FORMULATION
APPLICATION
“
”
SERVICE LIFE
“
WASTE
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Example 2 Disinfection of animal housing
Time
No. of cows
Maximum per ha
N / P2O5
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Moment of
manuring
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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
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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.
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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.
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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.
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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.
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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.
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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 
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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
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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)
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ESDs for Main Group 2 (preservatives)
• 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)
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ESDs for Main Group 2 (preservatives)
• 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)
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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
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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 
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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 
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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
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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
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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..
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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.
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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.
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