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New EU-chemical policy. Overall Objective. Sustainable development in Europe by: Protection of humans and environment Improvement of the chemical industry’s competitiveness in EU Larger transparency for the consumers

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New eu chemical policy

New EU-chemical policy


Overall objective

Overall Objective

Sustainable development in Europe by:

Protection of humans and environment

Improvement of the chemical industry’s competitiveness in EU

Larger transparency for the consumers

Promotion of tests without the use of experimental animals

Accordance with WTO obligations


The chemical pressure

”The chemical pressure”

+ ELINCS

(2.700)

New substances

since 1981

Full knowledge

Limited

knowledge

App. 10.000

substances

used in

the paint

industry

Existing

substances in 1981

EINECS

(app. 100.000)

App. 30.000

substances

produced

today > 1 ton


Shift in responsibility

Shift in responsibility

  • The present system:

    • Producers of chemicals: Classification of danger (Hazard).

    • Authorities/EU make risk assessment==> burden of proof lies with the authorities

  • The future system:

    • Producers of chemicals + ”downstream users” (especially exposure data) responsible for data and risk assessment.==> the burden of proof lies with the industry


Where is our industry in this connection

Where is our industry in this connection?


New eu chemical policy

Registration

UPSTREAM

Production

Chem.substances

(A1,A2 additives;

M1, M2 monomers)

A1

A2

M1

M1

Cobolt

Terpentin

Data on

consumption/

exposure

Raw materials

(pigments,

binders, etc)

Polymer

Ex. Binder

Physical

goods

Agent

Danger

data

Products

paint,adhesives,etc

Ex. varnish

Consumption

(DIY, Prof., Industry)

Ex. Production of windows

DOWNSTREAM


Risk assessment

Risk assessment

Risk = Hazard x Exposure

Data obligation: Producer of chemicals Downstream user


Categorisation of hazard

Categorisation of hazard

Low

Medium

High

SVHC*)

CMR cat. 1 and 2

Hormonlike substances

POP

PBT + vPvB

(very persistent, very

bioaccumulating

and toxic substances)

Human

Xn,Xi

Giftig

Meget Giftig

Environ-

ment

R53 **)

Miljøfarlig

Miljøfarlig

*) Substances of Very High Concern

**) R53: May cause unwanted longtime effects to the aquatic environment


Exposure environment humans

ExposureEnvironment + Humans

Time

Quantity

Types

of

use

How long

How often

How much

How


Risk assessment1

Risk Assessment

Increasing

risk

Increasing

exposure

High risk

Medium risk

Low risk

Increasing

danger


Reach unity s ystem for all chemicals

Registration Includes data on physical-chemical properties, hazard and exposure/use which together create the basis for a risk assessment

Evaluation

Quality control of presented registration data for substances >100 t/y and especially problematic substances.

Permission for and additional request for tests can be demanded during the evaluation.

Authorization of

CHemicals

Especially problematic substances must be authorized for

any use of which they are a part.

Prof.

Ind.

Eksample.

REACHUnity system for all chemicals:

DIY


Reach time schedule according to draft order may 2003

REACH Time Schedule (according to draft order May 2003)

Quantity

2006

09

11

15

17

20

12

år

Registration

> 1 t/y

Registration

Eval.

>100 t/y

18 months pre-registration

> 1000 t/y

Reg.

E.

Substances to be authorised

CMR cat. 1, 2


New eu chemical policy

2700 ELINCS substances

E

CH

R

A

Substances with obligatory authorization

30.000 of 100.000 EINECS substances

>1000 t/y

>100 t/y

>10 t/y

>1 t/y


Registration costs

Registration Costs


How much does reach cost

How much does REACH cost?

Billion €

  • Total costs (RPA/commission)3,6

  • Total costs (CEFIC)7,1

  • Total costs (UK study)8,7

  • Indirect costs (CEFIC)14 - 26

  • Hospital savings (30-year period)18 – 54

  • 2 % of the French working force (French study)

  • 150.000 - 2.000.000 german jobs (ADL-study)


Eu legislation process

EU Legislation process

General

Where are we in the process on the EU Chemical policy?


Eu s most important institutions

EU’s most important institutions

  • COMMISSION: Appointed by the governments of the member countries for 5 years.

    Initiator of legislation

  • COUNCIL of MINISTERs: Government Representatives from member countries. Legislative function

  • PARLIAMENT: Directly elected and party organised. Cooperates with the Council in the legislation process


Sources of law

SOURCES OF LAW

  • EU Regulations: Immediately valid in the member countries after publication

  • Directives: Must go through an implementation phase in the member countries prior to becoming effective


The danish parliament s europe committee

The Danish Parliament’s Europe Committee

  • The Committee gives mandate to the Government

  • Coordinates across the Parliament’s line-committees and interacts with the Government

    In addition to this

  • The Parliament’s public information, debate and dialogue on the EU policy.

  • Co-operates with the other countries’ parliaments and Europe-committees


New eu chemical policy

EU Legislation process

TIme

2001

White paper

Work up

Interservice

Internet consultation

Proposal on EU regulation

EU-Commission

Now

Autumn

2003?

European Parliament

EU Council of Ministers

++ year

EU Regulation

New EU chemical legislation

2006?


Dialogue with authorities

Dialogue with authorities

European level:

National level:

- CEPE, FEICA etc.

- The Danish Paintmakers’ Association

- The Danish Adhesives & Sealants Association

- The Co-operation & Information Committee of the Sealant Industry


New eu chemical policy

Generally:

We support the initiative for a

new EU chemical legislation,

but….

It must be operational


New eu chemical policy

PRIMARILY

TECHNICAL

DIALOGUE

PRIMARILY

POLITICAL

DIALOGUE

White paper

Work up

Interservice

Internet consultation

Proposal on EU regulation

EU-Commission

European Parliament

EU Council of Ministers

EU regulation

New EU chemical legislation


New eu chemical policy

CEFIC

DUCC

European

ex. CEPE

- ’Advocacy’ group

- Technical group

Project in FDLF

Danish Association

White paper

Work up

Interservice

Internet consultation

Proposal on EU regulation

EU-Commission

European Parliament

EU Council of Ministers

EU regulation

New EU chemical legislation


Internet hearing 8 weeks finishes 10th july 2003

Internet hearing8 weeks - finishes 10th July, 2003

  • Present phase: CEPE work

    • Technical working group

    • ’Advocacy’ group

  • Medio/ultimo June: Request from CEPE/ FEICA for national input (via FDLF and the Adhesives Association).


Other dialogue with authorities

Other dialogue with Authorities

  • EU Parliament

    • 29. April: EU Event arranged by CEPE

    • 13. May: Meeting with Danish parlamentarians arranged by FDLF

      Council of Ministers

    • Letter from FDLF to the Danish Minister for the Environment

    • Meeting with

      • The Minister for the Environment?

      • The Minister for Trade & Economic Affairs?

      • The Parliament’s Europe Committee?

      • The Parliament’s Environment- & Planning Committee?

      • Future EU-parlamentarians?


New eu chemical policy

EU’s new chemical policyProject in Danish Industry

  • The Danish Paintmakers’ Association

  • The Danish Adhesives & Sealants Association

  • The Co-operation & Information Committee of the Sealants Industry


Purpose

Purpose

  • Preparation of an action plan for the implementation of EU’s chemical policy into the individual companies.

  • As “a side effect”:

    • Identify specific problems of the industry especially concerning ”workability” – is the legislation operational?


Economic framework

Economic framework

A grant of 4.328.000 DDK from the

DK-EPA for a 3-years project

The Industry’s own finansing is DDK 2.885.750

(to be calculated as hours provided by the individual companies during the project)


New eu chemical policy

Phase 1: Core project

EU Chemical strategy plan

Education &

Information

The industry

(decision makers + technicians) Prephase

Tools

Pilot 1

The industry

(decision makers + technicians)

The industry

(decision makers + technicians)

Pilot 2

Pilot 3

The industry

(decicion makers + technicians)

The industry

(decision makers + technicians)

+ Prof. customers

+ general public

Action plan for implemetation of the new EU Chemmical policy in the individual company.

Fase 2 ?


New eu chemical policy

Temperature

measuring

Health test

Treatment plan

Phase 1: Core projekt

EU Chemical strategy plan

Education &

Information

The industry

(decision makers + technicians) Prephase

Tools

Pilot 1

The industry

(decision makers + technicians)

The industry

(decision makers + technicians)

Pilot 2

The industry

(decision makers + technicians)

Pilot 3

The industry

(decision makers + technicians)

+ Prof. customers

+ General public

Action plan for the individual company for implementation of

EU’s chemical policy

Phase 2 ?


Expected results

Expected results

  • The project is expected to have the following specific results:

    • Tools for the practical handling of the chemical policy in the individual company

    • An understanding in the companies of how the work and the new general view can be used in f. ex. product development and marketing

    • A dialogue with both ”downstream -” and ”upstream user”


Expected results continued

Expected results (continued)

  • A number of pilot studies

  • A seminar and an education presenting the pilot comnaies’ experience with the chemical strategy plan

  • An overview of the consequences, which EU’s chemical policy will have for the industry

  • A general action plan for the companies’ implementation of the chemical policy


Project staff

Project staff

  • Claus Ankjærgaard, Hempel (60%)

  • Per Langholz, Dyrup (10%)

  • Luise Nørgaard-Andersen, Dyrup (50%)

  • Dorthe Christensen, Dana Lim (30%)

  • Project management: Vibeke Plambeck


Internal steering group

Internal Steering group

  • Vibeke Plambeck, FDLF (responsible)

  • Eva Bie Kjær, Hempel

  • Claus Birch, Dana Lim

  • Helle Simon Elbro, Dyrup

  • Walter Sebastian, FSO

  • Stig Hirsbak, Rambøll

  • Ivan Grønning, BASF


Internal follow group msu fdlf association of danish paint and lacquer organisation

Internal Follow-Group = MSUFDLF: Association of danish paint and lacquer organisation.

  • Helle Simon Elbro, Dyrup (chairman)

  • Eva Bie Kjær, Hempel

  • Diana Schou, Esbjerg Farve- og Lakfabrik A/S

  • Jesper Hougesen, Beck & Jørgensen A/S

  • Jørgen Olsen, Beth Gydesen, Akzo Nobel Deco A/S

  • Rikke Østergaard, Teknos A/S

  • Poul Bastholm, Flügger A/S

  • Anders Fogh, Sicpa AB

  • Vibeke Plambeck, FDLF


External follow group

External Follow-group

  • Vibeke Plambeck, FDLF (project-responsible)

  • Inge Werther, DK-EPA

  • Representative from DK-EPA, Area of Chemicals

  • Helle Simon Elbro, Dyrup

  • Eva Bie Kjær, Hempel

  • Walter Sebastian, FSO

  • Stig Hirsbak, Rambøll

  • Ivan Grønning, BASF A/S


Temperature measurement in company x preliminary considerations on consequences

Temperature measurementin Company XPreliminary considerations on consequences


General process of the project 1 temperature measurement in company x

General process of the project1) Temperature measurement in Company X

Temperature ==> Health test ==> Treatment plan

Pilot 1 ==> Pilot 2 ==> Pilot 3 ==> ………….

2003 2005


Temperature measurement in company x

Temperature measurement in Company X

  • Measuring high volume substances: HPVC

  • Measuring low volume substances: LPVC

  • Measuring SVHC - Substances potientially to be authorized


Production volume of the substances

Production volume of the substances

Ton/producer/yea

10

100

1000

1

REACH

Regulation

categories

HPVC

LPVC

ECB*)

data

*) European Chemicals Bureau data originate from

- The regulation on risk assessment of existing substances from 1993

- Data reported from 1990 and forwards

- HPVC = High Production/import Volume Chemicals (”high volume”)

- LPVC = Low Production/import Volume Chemicals (”low volume”)


Reach time schedule according to draft for regulation may 2003

LPVC

HPVC

REACH Time schedule (according to draft for regulation May 2003)

Quantity

2006

09

11

15

17

20

12

år

Registration

> 1 t/y

Registration

Eval.

>100 t/y

> 1000 t/y

Reg.

E.

18 months pre registration

Substances with obligatory authorization

CMR cat. 1, 2


Snowball effect

Snowball effect

SubstancesRaw materialsRecipes/Products

(100x) (100x) (100x)

Average:

60 substances

per. recipe

Average:

3 substances

per. Raw mat.

Average:

20 raw mat.

per. recipe


Temperature measurement

The higher the volume -

the earlier action must be

taken

Temperature measurement

Measuring high volume substances


Determination of hpvc s method

Determination of HPVC’sMethod

ECB’s HPVC list

Company x’s recipes

Company x’s list of raw materials

Firma x’s list of substances


Measuring high volume substances hpvc

Measuring high volume substances(HPVC)

Substances

App. 70 % is HPVC

App. 80 % of raw

materials contain

min. one HPVC.

Raw

materials

100 % of recipes will

be affected by the

legislation in 2009.

Products


Measuring high volume substances hpvc action plan for company x

Measuring high volume substances (HPVC)Action plan for COMPANY X

  • COMPANY X has HPVC’s in almost all products!

  • Action must be taken before 2009!

  • Action: Dialogue between raw material supplier Y and COMPANY X.

    • Will all HPVC’s used in COMPANY X’s raw materials be

      approved by raw material supplier Y for use in

      COMPANY X’s products?


Temperature measurement1

The lower volume - the

greater the risk of not

surviving for economicall

reasons.

Temperature measurement

Measuring low volume substances


New eu chemical policy

Measuring low volume substances (LPVC)Some LPVC’s disappear, because they are too expensive to registrer

>1

>10

>100

>1000

>10000

Produced volume

tons/producer/year

10.000

0

1

10

100

1000

CEFIC estimate: 20-40% of low volume substances will not be registered

Commission estimate: 8-12 % of ALL substances will not be registered


New eu chemical policy

Determination of LPVC’s

Company x’s recipes

Company x’s list of raw materiale

Firma x’s list of substances

ECB’s LPVC list


Measurement of low volume substances lpvc

Assumption: 30% of LPVC

disappears.

Measurement of low volume substances(LPVC)

Substances

Ca. 30 % is LPVC

Ca. 45 % of raw

materials contains

min. one LPVC.

Raw mat.

80 % of the recipes

contain min.

one LPVC.

Products


Measurement of low volume substances 1t consequences

Will it be possible at all ?

- and what is the environmen-

tal improvement ?

Measurement of low volume substances (>1t)Consequences

R.I.P

2017

2015

Registration

Pre registration

18 + 2 months

Reservered time for reformulation of

the part of the product range

containing LPVC which will be dropped

(possible scenario 40%)


Time of registration depends on production volume year producer

Potentially the same

product must be

changed 3 times

= suboptimization

Time of Registrationdepends on production volume/year/producer

Time of Registra-

tion

> 1 tons

> 100 tons

> 1000 tons

2009

2017

2012

Many recsipes

contain substances

from all volume

categories


Temperature measurement2

Potentially SVHC will have

Compulsory authorisation

Temperature measurement

Measuring SVHC

Substances of Very High Concern


Risk assessment2

Risk assessment

Increasing

risk

Increasing

exposure

High risk

Medium risk

Low risk

Increasing

danger


Measuring svhc substances with potentially compulsory authorization

Measuring SVHCSubstances with potentially compulsory authorization

Humans

Environment

very

Persistent

very

Bioaccumulative

Carcinogenic

Mutagenic

Reprotoxic

Persistent

Bioaccumulative

Toxic

Hormonlike


New eu chemical policy

Method for determination of SVHC

Substances with potentially compulsory authorization

Company x’s recipes

Company x’s list of raw materials

Company x’s list of substances

Classified substances

The EPA’s list for self classification

US EPA’s PBT-profiles

(POP-substances)


Measuring svhc substances with potentially compulsory authorization1

Measuring SVHCSubstances with potentially compulsory authorization

Substances

5-10 % is SVHC

10-15 % of raw matr.

contain min.

one SVHC.

Raw matr.

Not known

SVHC is not evenly

distributed

Products


Which considerations should company x have concerning svhc in their raw materials

Which considerations should COMPANY X have concerning SVHC in their raw materials ?

  • Concentration in relation to minimal limit (f.ex. the impurity benzene in white spirit).

  • Why do we use the substance? Can it be justified

  • technically and economically? (f.ex. siccatives)

  • Is there possibility for substitution involving less risk?


New eu chemical policy

What does COMPANY X know now?Result of Temperature measurement

  • Time frame for when to react (Measuring HPVC).

  • The first evaluation concerning how many recipes must be reformulated because of lacking support from the raw materials suppliers (Measuring LPVC).

  • Get an indication of which raw materials contain problematic substances (SVHC).

  • Get the first input for a dialogue between the company and it’s raw material suppliers (f.ex. Exposure data).


New eu chemical policy

Registration

UPSTREAM

Production

chemical substances

(A1,A2 additives;

M1, M2 monomers)

A1

A2

M1

M1

Cobolt

Terpentin

Data on

consumption/

esposure

Raw materials

(pigments,

binders, etc)

Polymer

Ex. Binder

Physical

goods

Agent

Danger

data

Products

(paint, adhesives, etc)

Ex. varnish

Consumption

(DIY, Prof., Industry)

Ex. Windows production

DOWNSTREAM


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