European
Chemicals
Bureau
Tools for risk assessment:
TGDs, EUSES
Sharon Munn
European Commission DG JRC,
Institute for Health and Consumer Protection
European Chemical Bureau
EU general process
Data collection (step-by-step
based on production volume)
Automatic priority setting
Management committee
National priority lists
EU priority list in official journal
Further data gathering
and/or risk assessment
Hazard Assessment
Exposure Assessment
Risk management; (if necessary)
incl. strategies for risk reduction
Tools to implement Regulation 793/93
1. Data Collection Step
HEDSET, IUCLID
2. Priority Setting Step
EURAM
3. Risk Assessment Step TGD - RA, EUSES
4. Risk Reduction Step
TGD - RR
TG D
ENVIRONMENT
Data requirements for new substances
additional studies
birds
bioaccumulation
bioaccumulation
prolonged fish
prolonged fish
earthworms
earthworms
higher plants
higher plants
Daphnia, 21-days
Daphnia, 21-days
algal growth
algal growth
algal growth
acute Daphnia
acute Daphnia
acute Daphnia
acute fish
acute fish
acute fish
bacterial inhibition
bacterial inhibition
bacterial inhibition
Biodegradation adsorption/desorption adsorption/desorption adsorption/desorption
biodegradation
biodegradation
biodegradation
none
0.01 0.1
1
10 / 100
1000
t/a
Comparison of the Data Requirements
Today:
New Substances
Existing
substances
REACH:
All Substances
0.01
0.1
1
10
100
1000 t/a
Implementation Tools of Regulation 793/93
1. Data Collection
IUCLID
HEDSET
Tools to implement Regulation 793/93
1. Data Collection Step
HEDSET, IUCLID
2. Priority Setting Step
EURAM
3. Risk Assessment Step TGD - RA, EUSES
4. Risk Reduction Step
TGD - RR
General Process
• Priority setting:
– Production volume only, e.g. OECD HPV Chemicals
Programme (currently 5235 substances on OECD
HPV List)
– Risk based priority setting system e.g. ESR
(EURAM), PBT Chemicals, WFD,
– According to use only (BPD)
Priority Setting Existing Substances
140
Priority
Substances
> 2000 HPVCs
> 100.000 EINECS substances
Priority lists:
factors which should be taken into account
• the effects of the substance to man or the environment;
• the exposure of man or the environment to the substance;
• the lack of data on the effects of the substance on man and the
environment;
• work already carried out in other fora;
• other Community legislation and/or programmes relating to
dangerous substances.
EURAM using IUCLID data
Substance may obtain high scores if, for example
– it is produced in large volumes
– is used in a dispersive manner
– persists in the environment
– is highly toxic to humans, animals or plants
– has long term/chronic effects
– is carcinogenic, mutagenic or toxic to reproduction (CMR)
– little is known about its properties, use or effects
EURAM
E U R AM - Pro g ra m m e
E U R isk R an kin g M eth od
R an kin g of all S u b stan ces
in IU C L ID ord ered b y d eg ree
of p oten tial ad verse effects
C om m en ts b y
C om p eten t A u th orities an d In d u stry
E xp ert Ju d g em en t S tag e
creates ad ju sted R an kin g
C om m ission P rop osal for
P riority L ist, D iscu ssion with
M em b er S tates, O E C D , In d u stry
M eetin g for F in al D ecision , P u b lication
in O fficial Jou rn al
1 st P riority L ist
2 n d P riority L ist
3 rd P riority L ist
4 th P riority L ist
Principles for risk assessment
• Part I
– General Introduction
– Human Health
• Part II
– Environment
• Part III
– Use of (Q)SARs,
– Use categories, …
• Part IV
– Emission Scenario Documents
Free available on ECB web page
http://ecb.jrc.it/tgdoc
Introduction of :
Instrument for the quantitative assessment of the
risks posed by new and existing chemical
substances and biocides to man and the
environment.
EUSES is a coordinated effort of:
• EU Member States
• The European Commission (DG ENV)
• The European Chemicals Bureau (JRC-ECB)
• The European Chemical Industry
Basic Framework of Risk Assessment Process
Data evaluation
Exposure assessment
Emission rates
Data set
Effects assessment
Single species
toxicity data
TGD
Extrapolation
Distribution
EUSES
PNEC
PEC
Risk characterization
PEC/PNEC
Modules of EUSES
Exposure assessment
Effects assessment
Release
Extrapolation
Effects
assessment
Workplace
exposure
to PNECs/MOS
STP
Local
Regional
distribution distribution
Consumer
exposure
Exposure of
humans/predators
Hydrocarbon
Block Method
Risk characterisation
Route-to-route
extrapolation
Spatial scales of EUSES
ARCTIC
MODERATE
TROPIC
CONTINENT
REGION
exchange
LOCAL ENVIRONMENT
air
background
concentrations
inflow
concentrations
water
water
water
sediment
sediment
natural
soil
natural
soil
agricultural
soil
agricultural industrial
soil
soil
exchange
Local emission and distribution
a ir
lo c a l e m is s io n s
grassland
agricultural
soil
leaching
groundwater
s e w a g e tre a tm e n t
p la n t
dilution
surface water
sedimentation
sediment
Emission Scenario Documents
TDG Part IV
–
–
–
–
–
–
–
–
–
IC-3 Chemical industry: Chemicals used in synthesis
IC-5 Personal/Domestic and IC-6 Public domain
IC-10 Photographic industry
IC-12 Pulp, paper and board industry
IC-13 Textile processing industry
IC-14 Paints, lacquers and varnished industry
BPT-9 Biocides used as preservatives
BPT-6,7&9 Biocides used as preservatives in paper coating and finishing
BPT 2 Private and public health area disinfectants and other biocidal
products
– …..
NEW
Emission Scenarios Documents
updating EUSES
PT Description
1
5
6
Human hygiene biocidal products
Drinking water disinfectants
In-can preservatives
- washing & cleaning fluids
- paints & coatings
- fluids for paper, textile & leather prod.
7
Film preservatives
- plastics
- paper & cardboard
Wood preservatives
Fibre, leather, rubber and polymer
preservatives
- textiles & fabrics
- leather & hides
- paper & cardboard
- rubber, polymers, etc.
8
9
PT Description
10 Masonry preservatives
11 Liquid-cooling and processing
preservatives
- cooling systems
12 Slimicides
- paper pulp
- mineral oil extraction
13 Metal working fluids preservatives
14 Rodenticides
15 Avicides
18 Insecticides
21 Antifouling
Non Available
Emission Scenarios Documents
and the Biocides Product Directive
PT
3
4
16
17
19
20
23
Description
Veterinary hygiene
Food and feed area
Molluscicides
Piscicides
Repellents and attractants
Preservatives for food and feedstocks
Control of other vertebrates
Environmental emission scenarios
• Training Course Materials in ECB website:
http://ecb.jrc.it/biocides/ESDs
Parameter
Density of the solid pahse
Density of the water phase
Density of air
Temperature
value
2500
1000
1.3
12
unit
kgsolid/msolid3
kgwater/mwater3
kgair/mair3
ºC
Surface water
[Suspended matter]
15
mgsolid/lwater
Suspended matter
Fraction solids in s.matter
Fraction water in s.matter
Fraction o.c. in s.matter
0.1
0.9
0.1
msolid3/msusp3
mwater3/msusp3
Kgoc/kgsolid
Sediments
Fraction solids in sed.
Fraction water in sed.
Fraction o.c. in sed. solids.
0.2
0.8
0.05
msolid3/msed3
mwater3/msed3
Kgoc/kgsolid
Soil
Fraction solids in soil
Fraction water in soil
Fraction o.c. in soil
Fraction o.m. in soil
0.6
0.2
0.02
0.034
msolid3/msed3
mwater3/msed3
Kgoc/kgsolid
Kgoc/kgsolid
Regional distribution
Human exposure: pathways
Environment
air
water
food
soil
Human indirect exposure routes
Air
crops
HUMANS
dairy products
Soil
cattle
meat
Groundwater
drinking water
Surface
water
fish
Modules of EUSES
Exposure assessment
Effects assessment
Release
Extrapolation
Effects
assessment
Workplace
exposure
to PNECs/MOS
STP
Local
Regional
distribution distribution
Consumer
exposure
Exposure of
humans/predators
Hydrocarbon
Block Method
Risk characterisation
Route-to-route
extrapolation
Existing Chemicals
General decision scheme
Decision Scheme
PEC/PNEC
NO
>1
no need for further
testing or risk reduction
YES
can further
info lower
PEC/PNEC?
YES
further testing to
lower PEC or PNEC
NO
Risk Reduction
Measures
Limitations of EUSES
• Chemical risk policy of the EC
• A model is always a “cartoon of reality”
• Model analysis and validation limited
• Expertise of user is important
– data evaluation (“garbage in - garbage out”)
– interpretation of results
Tools for Risk Assessment of Chemicals
IUCLID4
International Uniform Chemical Information Database
TGD
Technical Guidance Documents
EUSES
Available to download for free at ECB website:
http://ecb.jrc.it/documents
What have we learned from using the TGD?
• THEOREM:
– Where there is “Clear guidance” there is less discussion
– Where there is “Some guidance” there is more discussion
– Where there is “Little Guidance” there is lots of discussion
• CORROLARY:
– The more discussion the more room for inconsistent decisions
and the slower the decision making
TGD and EUSES under REACH ?
• Basic principles will apply
• Industry will have to demonstrate safe use of chemicals
through Risk Assessment
• Manufacturers/Importers vs (Downstream) Users: who
does what
• Challenge to develop appropriate guidance
• Use of QSARs and category approaches
REACH information available on:
• ECB, European Chemicals Bureau
http://ecb.jrc.it/REACH
•
•
•
•
•
•
•
•
CLEEN, Chemicals Legislation European Enforcement Network
http://www.cleen-eu.net
DG Enterprise: REACH
http://europa.eu.int/comm/enterprise/reach
DG Enterprise: REACH calls for tender
http://europa.eu.int/comm/enterprise/reach/calls.htm
DG Environment: REACH
http://europa.eu.int/comm/environment/chemicals/reach.htm