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E uropean C hemicals B ureau. 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).

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tools for risk assessment tgds euses

European

Chemicals

Bureau

Tools for risk assessment:TGDs, EUSES

Sharon Munn

European Commission DG JRC,

Institute for Health and Consumer Protection

European Chemical Bureau

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

slide2

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

Hazard Assessment

Further data gathering

and/or risk assessment

Exposure Assessment

Risk management; (if necessary)

incl. strategies for risk reduction

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

slide3

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

T

D

G

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

environment
ENVIRONMENT

additional studies

birds

bioaccumulation

prolonged fish

earthworms

higher plants

Daphnia, 21-days

algal growth

acute Daphnia

acute fish

bacterial inhibition

adsorption/desorption

biodegradation

1000 t/a

bioaccumulation

prolonged fish

earthworms

higher plants

Daphnia, 21-days

algal growth

acute Daphnia

acute fish

bacterial inhibition

adsorption/desorption

biodegradation

10 / 100

Data requirements for new substances

algal growth

acute Daphnia

acute fish

bacterial inhibition

adsorption/desorption

biodegradation

1

Biodegradation

0.1

none

0.01

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

slide5

Comparison of the Data Requirements

Today:

New Substances

Existing

substances

REACH:

All Substances

0.01 0.1 1 10 100 1000 t/a

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

slide6

Implementation Tools of Regulation 793/93

  • Data Collection HEDSET
  • IUCLID

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

slide7

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

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

slide8

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)

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

slide9

Priority Setting Existing Substances

140

Priority

Substances

> 2000 HPVCs

> 100.000 EINECS substances

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

priority lists factors which should be taken into account
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.

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

slide11

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

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

slide12

EURAM

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

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

Principles for risk assessment

Free available on ECB web page

http://ecb.jrc.it/tgdoc

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

slide14

Introduction of :

Instrument for the quantitative assessment of the risks posed by new and existing chemical substances and biocides to man and the environment.

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

slide15

EUSES is a coordinated effort of:

  • EU Member States
  • The European Commission (DG ENV)
  • The European Chemicals Bureau (JRC-ECB)
  • The European Chemical Industry

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

basic framework of risk assessment process

Data evaluation

Basic Framework of Risk Assessment Process

Exposure assessment

Effects assessment

Data set

Single species

toxicity data

Emission rates

TGD

Extrapolation

Distribution

EUSES

PNEC

PEC

Risk characterization

PEC/PNEC

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

modules of euses

Exposure assessment

Effects assessment

Release

Extrapolation

to PNECs/MOS

Effects assessment

STP

Workplace

exposure

Local

distribution

Regional

distribution

Route-to-route

extrapolation

Consumer

exposure

Exposure of

humans/predators

Hydrocarbon

Block Method

Risk characterisation

Modules of EUSES

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

spatial scales of euses

ARCTIC

MODERATE

TROPIC

CONTINENT

REGION

LOCAL ENVIRONMENT

air

exchange

exchange

background

concentrations

water

inflow

water

concentrations

natural

soil

agricultural

soil

water

sediment

natural

soil

agricultural

soil

industrial

soil

sediment

Spatial scales of EUSES

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

local emission and distribution

deposition

agricultural

grassland

soil

volatilization

leaching

sludge application

groundwater

dilution

surface

water

sedimentation

sediment

Local emission and distribution

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

emission scenario documents
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
  • …..

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

new emission scenarios documents updating euses

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

NEW Emission Scenarios Documents updating EUSES

PT Description

1 Human hygiene biocidal products

5 Drinking water disinfectants

6 In-can preservatives- washing & cleaning fluids- paints & coatings- fluids for paper, textile & leather prod.

7 Film preservatives- plastics- paper & cardboard

8 Wood preservatives

9 Fibre, leather, rubber and polymer preservatives- textiles & fabrics- leather & hides- paper & cardboard- rubber, polymers, etc.

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

non available emission scenarios documents and the biocides product directive
Non AvailableEmission Scenarios Documents and the Biocides Product Directive

PT Description

3 Veterinary hygiene

4 Food and feed area

16 Molluscicides

17 Piscicides

19 Repellents and attractants

20 Preservatives for food and feedstocks

23 Control of other vertebrates

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

environmental emission scenarios
Environmental emission scenarios
  • Training Course Materials in ECB website: http://ecb.jrc.it/biocides/ESDs

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

slide24

Parameter value unit

Density of the solid pahse 2500 kgsolid/msolid3

Density of the water phase 1000 kgwater/mwater3

Density of air 1.3 kgair/mair3

Temperature 12 ºC

Surface water

[Suspended matter] 15 mgsolid/lwater

Suspended matter

Fraction solids in s.matter 0.1 msolid3/msusp3

Fraction water in s.matter 0.9 mwater3/msusp3

Fraction o.c. in s.matter 0.1 Kgoc/kgsolid

Sediments

Fraction solids in sed. 0.2 msolid3/msed3

Fraction water in sed. 0.8 mwater3/msed3

Fraction o.c. in sed. solids. 0.05 Kgoc/kgsolid

Soil

Fraction solids in soil 0.6 msolid3/msed3

Fraction water in soil 0.2 mwater3/msed3

Fraction o.c. in soil 0.02 Kgoc/kgsolid

Fraction o.m. in soil 0.034 Kgoc/kgsolid

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

slide25

Regional distribution

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

human exposure pathways

Environment

air water food soil

Consumer

products

Occupational

environment

dermal

inhalation

oral

Human exposure: pathways

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

human indirect exposure routes

Air

crops

HUMANS

dairy products

Soil

cattle

meat

Groundwater

drinking water

Surfacewater

fish

Human indirect exposure routes

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

modules of euses28

Exposure assessment

Effects assessment

Release

Extrapolation

to PNECs/MOS

Effects assessment

STP

Workplace

exposure

Local

distribution

Regional

distribution

Route-to-route

extrapolation

Consumer

exposure

Exposure of

humans/predators

Hydrocarbon

Block Method

Risk characterisation

Modules of EUSES

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

decision scheme

Existing ChemicalsGeneral decision scheme

PEC/PNEC

> 1

Decision Scheme

NO

no need for further

testing or risk reduction

YES

can further info lower PEC/PNEC?

NO

Risk Reduction

Measures

YES

further testing to

lower PEC or PNEC

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

limitations of euses
Limitations of EUSES
  • A model is always a “cartoon of reality”
  • Chemical risk policy of the EC
  • Model analysis and validation limited
  • Expertise of user is important
    • data evaluation (“garbage in - garbage out”)
    • interpretation of results

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

tools for risk assessment of chemicals
Tools for Risk Assessment of Chemicals

IUCLID4International Uniform Chemical Information DatabaseTGDTechnical Guidance DocumentsEUSES Available to download for free at ECB website:http://ecb.jrc.it/documents

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

what have we learned from using the tgd
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

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

tgd and euses under reach
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

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006

reach information available on
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

ECB INFODAYS Zagreb, Croatia, 11-13 December 2006