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

2. 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

3. Elements of ‘Chemicals Control’
Data collection and exchange of information
Classification and labelling
Risk assessment
Risk management (a.o. authorisation)

4. The EU Biocidal Products Directive (1998)
Why ? : Risk Management !
Whereas 1: ‘ Council .. need for risk management of non-agricultural 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, ...

5. Environmental Risk Assessment: Basic Framework
Data set
Data evaluation
Emissions
Distribution
PEC
Exposure assessment
Single species
toxicity data
Extrapolation
PNEC
Effects assessment
TGD
EUSES
PEC/PNEC
Risk characterization 2 3 3

6. Life cycle PRODUCTION FORMULATION PRIVATE USE INDUSTRIAL USE
SERVICE LIFE
PRIVATE USE
INDUSTRIAL
USE
In product
Processing
aid
WASTE DISPOSAL
- Incineration -
Landfilling
- Recovery
Life cycle

7. Local emission and distribution routes
Air
Deposition
Agricultural
Local emissions
Grassland
soil
Volatilization
Leaching
Sludge application
Groundwater
Surface
STP
Dilution
water
Sedimentation
Sediment 13 11 11

8. Indicative food chains
SOIL
POREWATER
PREDATORS
earthworm
SURFACE
WATER
fish

9. 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

10. Effects assessment
laboratory testing (single species; standardised test)
various trophic levels
algae +
crustacea
fish
Aquatic ecosystem ?

11. PNEC derivation (water)
Data Assessment factor
Short-term L(E)C50 from each of three trophic levels of 1000
the base-set (fish, daphnia, algae)
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)
Long-term NOECs from at least three species representing 10
three trophic levels (normally fish, Dapnia, algae)
Field data or model ecosystems case by case

12. 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

13. Experience of initial vs. refined RAs
Uncertainty Factor
__________________________________________
PNEC ± 10
emission rates > 1000
STP emission estimation < 10
biodegradation in surface water < 10
exposure assessment PEC > 10,000

14. E m i s s i o n S c e n a r i o s

15. 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.

16. Life Cycle & Risk Assessment
New &
Existing
Substances
PRODUCTION
FORMULATION
APPLICATION
SERVICE LIFE
WASTE
Biocidal
Products
Directive
Local &
Regional
Scale
Local
Scale

17. Next stage of life cycle
Local scale
(1 point source
for each life
cycle stage)
AIR
100 m
Process
Next stage
of life cycle
Wastewater
STP
SOIL

18. Regional scale Production P P (all sources all stages of l.c.)
Formulation
Industrial use I I I P I I I F I I F F I I P

19. Process Factors of Importance Industrial category
Function of substances
Process
Quantity of product
Content in product
Emission factor(s)

20. 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

21. Emission Scenario 1: Tonnage of Substance
INPUT:
EF Emission factor (-)
Tem Number of emission days (d.yr-1)
Q Tonnage (tonnes.yr-1)
Fms Fraction of the main source (-)
Emission = Q * Fms * EF / Tem * 10-3 (kg.d-1)
Main Source
Tonnage
Water
Air
Soil
Waste
Emission
factors
No. of days

22. Emission Scenario 2: Scale of Process
INPUT:
Qp Tonnage of product (tonnes.d-1)
EF Emission factor (-)
Qs Quantity of substance (kg.tonne-1 product)
Emission = Qp * Qs * EF (kg.d-1)
Emission Factor

23. 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)

24. 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, . . .

25. Biocides (Use Category 39)
Biocidal Products Directive 98/8/EG
Annex V
23 biocidal product types
Biocides

26. EU Biocidal Products Directive
23 Product Types divided over 4 Groups:
I DISINFECTANTS & GENERAL BIOCIDES
II PRESERVATIVES
III PEST CONTROL PRODUCTS
IV OTHER BIOCIDES

27. 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

28. II PRESERVATIVES 6 In-can preservatives 7 Film preservatives
8 Wood preservatives
9 Fibre, leather, rubber and polymerised materials preservatives
10 Masonry preservatives
11 Preservatives for liquid cooling and processing systems
12 Slimicides
13 Metalworking-fluid preservatives

29. III PEST CONTROL PRODUCTS
14 Rodenticides
15 Avicides
16 Molluscicides
17 Piscicides
18 Insecticides, acaricides & products to control other arthropod species
19 Repellents and attractants

30. IV OTHER BIOCIDES 20 Preservatives for food or feedstocks
21 Antifouling products
22 Embalming and taxidermist fluids
23 Control of other vertabrates

31. Deodorants, antiperspirants Anti-dandruff shampoo Antimicrobial soap
Example 1
Pt 1 : Human Hygiene Biocidal Products
PRODUCTION
FORMULATION
PRIVATE USE
SERVICE LIFE
WASTE
For example:
Deodorants, antiperspirants
Anti-dandruff shampoo
Antimicrobial soap
Etc.
Skin application
Short term
Bathing

32. Emission Scenarios of New & Existing Substances a) Tonnage
Example 1 Pt 1 : Human Hygiene Biocidal Products
Emission Scenarios of New & Existing Substances
a) Tonnage
b) Average consumption per inhabitant

33. Example 2 Pt 3 : Veterinary Hygiene Biocidal Products
3.1 Disinfection of animal housing
3.2 Disinfection of footwear and animals’feet
3.3 Disinfection of milk extraction systems
3.4 Disinfection of means of transport
3.5 Disinfection of hatcheries
3.6 Disinfection of fishfarms

34. “ ” “ ” Example 2 Disinfection of animal housing PRODUCTION
FORMULATION
APPLICATION
SERVICE LIFE
WASTE
“ ”
“ ”

35. Example 2 Disinfection of animal housing
Time
No. of cows
Moment of
manuring
Maximum per ha
N / P2O5

36. The EUBEES projects EUBEES
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

37. 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.

38. 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.

39. 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.

40. 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.

41. 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 The draft ESD is intended to be finalised early 2004 and submitted to the OECD JM end 2004.

42. 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 

43. 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

44. 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)

45. 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)

46. 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)

47. 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

48. 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 

49. 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 

50. 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
> documents

51. 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

52. 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..

53. 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.

54. 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.