Munn Ra Tools Tgd Euses Dec 11-13 Zagreb

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

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 Risk management; (if necessary) incl. strategies for risk reduction ECB INFODAYS Zagreb, Croatia, 11-13

Hazard Assessment Exposure Assessment

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

ECB INFODAYS Zagreb, Croatia, 11-13

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

ECB INFODAYS Zagreb, Croatia, 11-13

1

10 / 100

1000

t/a

Comparison of the Data Requirements

Today: New Substances Existing substances REACH: All Substances 0.01

0.1

1

ECB INFODAYS Zagreb, Croatia, 11-13

10

100

1000 t/a

Implementation Tools of Regulation 793/93

• Data Collection

IUCLID

ECB INFODAYS Zagreb, Croatia, 11-13

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

ECB INFODAYS Zagreb, Croatia, 11-13

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)

ECB INFODAYS Zagreb, Croatia, 11-13

Priority Setting Existing Substances

140 Priority Substances > 2000 HPVCs

> 100.000 EINECS substances

ECB INFODAYS Zagreb, Croatia, 11-13

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

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

EURAM E U R A M - P ro g ra m m e E U R is k R a n k in g M e t h o d

R a n k in g o f a ll S u b s t a n c e s in I U C L I D o r d e r e d b y d e g r e e o f p o t e n t ia l a d v e r s e e ffe c t s

C o m m e n ts b y C o m p e t e n t A u t h o r it ie s a n d I n d u s t r y

E x p e rt J u d g e m e n t S ta g e c r e a t e s a d ju s t e d R a n k in g

C o m m is s io n P r o p o s a l fo r P r io r it y L is t , D is c u s s io n w it h M e m b e r S ta te s , O E C D , In d u s try

M e e t in g fo r F in a l D e c is io n , P u b lic a t io n in O ffic ia l J o u r n a l

1 s t P r io r it y L is t

ECB INFODAYS Zagreb, Croatia, 11-13

2 n d P r io r it y L is t

3 r d P r io r it y L is t

4 t h P r io r it y L is t

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

ECB INFODAYS Zagreb, Croatia, 11-13

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

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

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

ECB INFODAYS Zagreb, Croatia, 11-13

Modules of EUSES Exposure assessment

Effects assessment

Release Extrapolation Effects assessment to PNECs/MOS

STP

Workplace exposure

Local Regional distribution distribution Consumer exposure

Exposure of humans/predators Hydrocarbon Block Method

ECB INFODAYS Zagreb, Croatia, 11-13

Risk characterisation

Route-to-route extrapolation

Spatial scales of EUSES ARCTIC

MODERATE

TROPIC

CONTINENT REGION exchange

air

LOCAL ENVIRONMENT

background concentrations

inflow concentrations

water water water sediment sediment

ECB INFODAYS Zagreb, Croatia, 11-13

natural soil

natural soil

agricultural soil

agricultural industrial soil soil

exchange

Local emission and distribution de

po

iliz ati

grassland

vo

lat

local emissions

on

air

p

plic

a ge

d

slu

sewage treatment plant

dilution

on i t a

sit

ion

agricultural soil leaching

groundwater

surface water sedimentation

sediment

ECB INFODAYS Zagreb, Croatia, 11-13

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 – …..

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

ECB INFODAYS Zagreb, Croatia, 11-13

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

ECB INFODAYS Zagreb, Croatia, 11-13

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

ECB INFODAYS Zagreb, Croatia, 11-13

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

0.6 0.2 0.02

msolid3/msed3 mwater3/msed3 Kgoc/kgsolid

Soil Fraction solids in soil Fraction water in soil Fraction ECB INFODAYS Zagreb, Croatia, 11-13 o.c. in soil

Regional distribution

ECB INFODAYS Zagreb, Croatia, 11-13

Human exposure: pathways Environment air Co pro nsum du e cts r

ECB INFODAYS Zagreb, Croatia, 11-13

oral

water

food

inha latio n

soil

derm

al

l a n o i at ent p cu nm c O viro en

Human indirect exposure routes Air crops

HUMANS dairy products

Soil cattle

meat

Groundwater drinking water Surface water fish

ECB INFODAYS Zagreb, Croatia, 11-13

Modules of EUSES Exposure assessment

Effects assessment

Release Extrapolation Effects assessment to PNECs/MOS

STP

Workplace exposure

Local Regional distribution distribution Consumer exposure

Exposure of humans/predators Hydrocarbon Block Method

ECB INFODAYS Zagreb, Croatia, 11-13

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 ECB INFODAYS Zagreb, Croatia, 11-13

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 ECB INFODAYS Zagreb, Croatia, 11-13

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

ECB INFODAYS Zagreb, Croatia, 11-13

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 ECB INFODAYS Zagreb, Croatia, 11-13 inconsistent decisions and the slower the

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

REACH information available on: • ECB, European Chemicals Bureau

ecb.jrc.it/REACH

http://

• 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 •

ECB INFODAYS Zagreb, Croatia, 11-13