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EU Project QLK1-CT2002-2390

Modelling migration from plastics


into
Modelling Migration fromfoodstuffs
Plastics intoas a novel and cost
Foodstuffs
efficient
as a Novel and Cost Efficient tool forEstimation
Tool for estimation
of of
Consumer Exposure from Food exposure
consumer Contact Materials
from food
contact materials
Project co-ordinator Project specifications

Dr Roland Franz Roland Franz, Contract: QLK1-CT2002-2390


Fraunhofer Institute Starting date: 01/03/2003
Fraunhofer
Process Engineering and Packaging IVV, Duration: 36 months
Giggenhauser Str. 35 Freising
85354 Freising GERMANY Scientific Officer:
Germany Dr Achim Boenke
Phone: ++49 (0)8161 491 746 European Commission
Fax.: ++49 (0)8161 491 777 DG Research
E-mail: roland.franz@ivv.fraunhofer.de E-mail: Achim.Boenke@cec.eu.int
IVV

Fraunhofer Institut IVV


Verfahrenstechnik Fraunhofer Institut
und Verpackung
Verfahrenstechnik
und Verpackung
EU Project QLK1-CT2002-2390
First of all:
Modelling Migration from Plastics into Foodstuffs
Thank you all
as a Novel and Cost Efficient Tool for Estimation of
Consumer Exposure from Food Contact Materials
for your interest
Project co-ordinator

Dr Roland Franz
in our project and Project specifications

Contract: QLK1-CT2002-2390
Fraunhofer Institute
for coming!
Process Engineering and Packaging
Giggenhauser Str. 35
Starting date:
Duration:
01/03/2003
36 months

85354 Freising Scientific Officer:


Germany Dr Achim Boenke
Phone: ++49 (0)8161 491 746 European Commission
Fax.: ++49 (0)8161 491 777 DG Research
E-mail: roland.franz@ivv.fraunhofer.de E-mail: Achim.Boenke@cec.eu.int
IVV

Fraunhofer Institut IVV


Verfahrenstechnik Fraunhofer Institut
und Verpackung
Verfahrenstechnik
und Verpackung
EU Project QLK1-CT2002-2390
Contents
• Why did we get into this project?
Modelling Migration from Plastics into Foodstuffs
[or:Efficient Tool for Estimation of
as a Novel and Cost
Consumer Exposure from Food Contact Materials
Why was the project unavoidable?]
Project co-ordinator Project specifications

Dr Roland Franz
• Intention & structure
Fraunhofer Institute
Contract:
of the project
QLK1-CT2002-2390
Starting date: 01/03/2003
Process Engineering and Packaging Duration: 36 months
Giggenhauser Str. 35
85354 Freising Scientific Officer:
Germany Dr Achim Boenke
Phone: ++49 (0)8161 491 746 European Commission
Fax.: ++49 (0)8161 491 777 DG Research
E-mail: roland.franz@ivv.fraunhofer.de E-mail: Achim.Boenke@cec.eu.int
IVV

Fraunhofer Institut IVV


Verfahrenstechnik Fraunhofer Institut
und Verpackung
Verfahrenstechnik
und Verpackung
EU Project QLK1-CT2002-2390
Why the project? Migration tests should be
Modelling Migration from Plastics into Foodstuffs
as a Novel and Cost Efficientand
simple Tool reproducible
for Estimation of
Consumer Exposure from Food Contact Materials

Project co-ordinator
and have therefore been carried out
Project specifications
so far using in the first place
Dr Roland Franz Contract: QLK1-CT2002-2390
Fraunhofer Institute Starting date: 01/03/2003
Process Engineering and Packaging Duration: 36 months
Giggenhauser Str. 35 food simulants
85354 Freising Scientific Officer:
Germany and not foodstuffs
Dr Achim Boenke .
Phone: ++49 (0)8161 491 746 European Commission
Fax.: ++49 (0)8161 491 777 DG Research
E-mail: roland.franz@ivv.fraunhofer.de E-mail: Achim.Boenke@cec.eu.int
IVV

Fraunhofer Institut IVV


Verfahrenstechnik Fraunhofer Institut
und Verpackung
Verfahrenstechnik
und Verpackung
EU Project QLK1-CT2002-2390
Why the project? On the other hand:
EUfrom
Modelling Migration legislation foresees
Plastics into that for
Foodstuffs
compliance
as a Novel and Cost Efficient Tool for Estimation of
Consumer Exposure from Food Contact Materials

the concentration (migration)


Project co-ordinator Project specifications
in food
Dr Roland Franz Contract: QLK1-CT2002-2390
Fraunhofer Institute Starting date: 01/03/2003
Process Engineering and Packaging Duration: 36 months
Giggenhauser Str. 35 is the crucial one compared to the
85354 Freising Scientific Officer:
Germany
Phone: ++49 (0)8161 491 746
food simulant
Dr Achim test
Boenke.
European Commission
Fax.: ++49 (0)8161 491 777 DG Research
E-mail: roland.franz@ivv.fraunhofer.de E-mail: Achim.Boenke@cec.eu.int
IVV

Fraunhofer Institut IVV


Verfahrenstechnik Fraunhofer Institut
und Verpackung
Verfahrenstechnik
und Verpackung
EU Project QLK1-CT2002-2390
Why the project? And:
Exposure
Modelling Migration estimation
from Plastics or assessment
into Foodstuffs
should
as a Novel and Cost (must)
Efficient beEstimation
Tool for based onof
Consumer Exposure from Food Contact Materials

the concentration (migration)


Project co-ordinator Project specifications
in food
Dr Roland Franz Contract: QLK1-CT2002-2390
Fraunhofer Institute Starting date: 01/03/2003
Process Engineering and Packaging Duration: 36 months
Giggenhauser Str. 35 and not on migration values in
85354 Freising Scientific Officer:
Germany
Phone: ++49 (0)8161 491 746
food simulants .
Dr Achim Boenke
European Commission
Fax.: ++49 (0)8161 491 777 DG Research
E-mail: roland.franz@ivv.fraunhofer.de E-mail: Achim.Boenke@cec.eu.int
IVV

Fraunhofer Institut IVV


Verfahrenstechnik Fraunhofer Institut
und Verpackung
Verfahrenstechnik
und Verpackung
EU Project QLK1-CT2002-2390
Why the project? Consequently,
Modelling Migration from Plastics into Foodstuffs
as a Novel and Cost Efficient Tool forisEstimation
a correlation of
needed between
Consumer Exposure from Food Contact Materials
food simulants and foods
Project co-ordinator Project specifications

Dr Roland Franz which is the Contract:


intentionQLK1-CT2002-2390
of
Fraunhofer Institute EU DirectiveStarting
Process Engineering and Packaging
85/572/EEC.
date: 01/03/2003
Duration: 36 months
Giggenhauser Str. 35
85354 Freising
Germany
However, problems were getting more
Scientific Officer:
Dr Achim Boenke
Phone: ++49 (0)8161 491 746 and more evident over the years .......
European Commission
Fax.: ++49 (0)8161 491 777 DG Research
E-mail: roland.franz@ivv.fraunhofer.de E-mail: Achim.Boenke@cec.eu.int
IVV

Fraunhofer Institut IVV


Verfahrenstechnik Fraunhofer Institut
und Verpackung
Verfahrenstechnik
und Verpackung
EU Project QLK1-CT2002-2390
Why the project? Food item RF
Relative migration
default measured
Modelling Migration from Plastics into Foodstuffs
Chocolate
as a Novel and Cost Efficientspread
Tool forX/3 0.33
Estimation of up to 1
Chocolate X/5 0.2 up to 1
Consumer Exposure from
Salami Food Contact
X/4 Materials
0.25 up to 0.88
Cocoa powder X/5* 0.2 up to 0.85
... for instance Mayonnaise (low fat) X/3 0.33 up to 0.83
Project co-ordinator Mayonnaise ProjectX/3 0.33
specifications up to 0.80
with these examples: Peanuts X/5* 0.2 up to 0.52
(where migration is
Dr Roland Franz Butter Contract:
X/2 QLK1-CT2002-2390
0.5 up to 0.57
Fraunhofer Institute Cheese (low fat) Starting date:
X/3* 0.33 01/03/2003 up to 0.19
given as relative
Process Engineering and Packaging Duration: 36 months
Whole milk (A) n.a. up to 0.27
valuesGiggenhauser
: Str. 35
Irish cream liqueur (C ) n.a. up to 0.45
85354 Freising Scientific Officer:
food / olive
Germany
oil) Flour (NT) 0
Dr Achim Boenke
up to 0.42
Phone: ++49 (0)8161 491 746 Buiscuit (rich tea) (NT)
European 0
Commission up to 0.58
(Source: EU Report
Fax.: ++4919376
(0)8161EN)491 777Bread (NT) 0
DG Research up to 0.08
E-mail: roland.franz@ivv.fraunhofer.de E-mail: Achim.Boenke@cec.eu.int
IVV

Fraunhofer Institut IVV


Verfahrenstechnik Fraunhofer Institut
und Verpackung
Verfahrenstechnik
und Verpackung
EU Project QLK1-CT2002-2390
Why the project?
Modelling Migration from Plastics into Foodstuffs
More recent examples from
as a Novel and Cost Efficient Tool for Estimation of
Consumer Exposure the ‚ITX
from crisis
Food ‘ [photo
Contact Materialsinitiator
in printing inks transferred to
Project co-ordinator food via set -off]
Project revealed
specifications

Dr Roland Franz
Fraunhofer Institute
again weaknesses
Contract: of the
QLK1-CT2002-2390
Starting date: 01/03/2003

Giggenhauser Str. 35
85/572/EC
Process Engineering and Packaging system
Duration: 36 months

85354 Freising Scientific Officer:


Germany Dr Achim Boenke
Phone: ++49 (0)8161 491 746 European Commission
Fax.: ++49 (0)8161 491 777 DG Research
E-mail: roland.franz@ivv.fraunhofer.de E-mail: Achim.Boenke@cec.eu.int
IVV

Fraunhofer Institut IVV


Verfahrenstechnik Fraunhofer Institut
und Verpackung
Verfahrenstechnik
und Verpackung
EU Project QLK1-CT2002-2390
Why the project?
ITX and Modelling
EHDAB Migration from Plastics into Foodstuffs
levels as
in a Novel and Cost Efficient Tool for Estimation of
“cloudy Consumer
“ drinksExposure from Food Contact Materials
(fruit juices/nectars)
Project co-ordinator Project specifications

Dr Roland Franz Contract: QLK1-CT2002-2390


Fraunhofer Institute ... altogether 45 products
Starting measured
date: 01/03/2003
Process Engineering and Packaging Duration: 36 months
Giggenhauser Str. 35 with found concentrations for
85354 Freising
(Source: EFSA opinion - ITX betweenScientific
20 ppb and 250 ppb
Officer:
Germany Dr Achim Boenke
on ITX and EHDAB in FCM,
Phone: ++49 (0)8161 491 746
- EHDAB between 10 ppb and 125 ppb
European Commission
dated 7 December 2005)
Fax.: ++49 (0)8161 491 777 DG Research
E-mail: roland.franz@ivv.fraunhofer.de E-mail: Achim.Boenke@cec.eu.int
IVV

Fraunhofer Institut IVV


Verfahrenstechnik Fraunhofer Institut
und Verpackung
Verfahrenstechnik
und Verpackung
EU Project QLK1-CT2002-2390
Why the project?
ITX and Modelling
EHDAB Migration from Plastics into Foodstuffs
levels as
in a Novel and Cost Efficient Tool for Estimation of
“clearConsumer
“ drinks Exposure from Food Contact Materials
(fruit juices/nectars)
Project co-ordinator Project specifications

Dr Roland Franz Contract: QLK1-CT2002-2390


Fraunhofer Institute Starting date: 01/03/2003
Process Engineering and Packaging
... altogether Duration:
17 products36measured
months
Giggenhauser Str. 35
85354 Freising
(Source: EFSA opinion
and in all cases found
Scientific Officer:concentrations
Germany Dr Achim Boenke
on ITX and EHDAB in FCM,
Phone: ++49 (0)8161 491 746 were not detectable , i.e < 5 ppb
European Commission
dated 7 December 2005)
Fax.: ++49 (0)8161 491 777 DG Research
E-mail: roland.franz@ivv.fraunhofer.de E-mail: Achim.Boenke@cec.eu.int
IVV

Fraunhofer Institut IVV


Verfahrenstechnik Fraunhofer Institut
und Verpackung
Verfahrenstechnik
und Verpackung
EU Project QLK1-CT2002-2390
Why the project?
ITX andModelling
EHDAB Migration from Plastics into Foodstuffs
levels as
in a Novel and Cost Efficient Tool for Estimation of
Consumer
milk and soy Exposure from Food Contact Materials
beverages
Project co-ordinator Project specifications

Dr Roland Franz Contract: QLK1-CT2002-2390


Fraunhofer Institute Starting date: 01/03/2003
Process Engineering and Packaging Duration: 36 months
Giggenhauser Str. 35
It should be noted that water and
85354 Freising
(Source: EFSA opinion 10% ethanol would give
Scientific Officer:
Germany Dr Achim Boenke
on ITX and EHDAB in FCM,
‘not detectables
Phone: ++49 (0)8161 491 746
dated 7 December 2005)
‘ (<Commission
European 5ppb)
Fax.: ++49 (0)8161 491 777 DG Research
E-mail: roland.franz@ivv.fraunhofer.de E-mail: Achim.Boenke@cec.eu.int
IVV

Fraunhofer Institut IVV


Verfahrenstechnik Fraunhofer Institut
und Verpackung
Verfahrenstechnik
und Verpackung
EU Project QLK1-CT2002-2390
Why the project?
... enormous progress has been made
Further
Modelling Migrationover
fromthePlastics into Foodstuffs
last decade in migration
advantageous
as a Novel and Costmodelling
Efficient Tool for Estimation
, in particular of
for mono -
circumstances
Consumer Exposure from Food
plastics Contactwith
in contact Materials
food simulants,
were that...
but also for multi-layer plastics.
Project co-ordinator Project specifications

Dr Roland Franz ... essential developments


Contract: have been
QLK1-CT2002-2390
Fraunhofer Institute made in the Starting
area date:of certified
01/03/2003 or
Process Engineering and Packaging Duration: 36 months
Giggenhauser Str. 35 certifiable reference plastics films in
85354 Freising relation to Scientific Officer:
migration relevant
Germany Dr Achim Boenke
Phone: ++49 (0)8161 491 746specifications .
European Commission
Fax.: ++49 (0)8161 491 777 DG Research
E-mail: roland.franz@ivv.fraunhofer.de E-mail: Achim.Boenke@cec.eu.int
IVV

Fraunhofer Institut IVV


Verfahrenstechnik Fraunhofer Institut
und Verpackung
Verfahrenstechnik
und Verpackung
Modelling Migration from Plastics into Foodstuffs
as a Novel and Cost Efficient Tool for Estimation of
Consumer Exposure from Food Contact Materials
Project co-ordinator Project specifications

Dr Roland Franz Contract: QLK1-CT2002-2390


Fraunhofer Institute Starting date: 1st January 2003
Process Engineering and Packaging IVV Duration: 43 months
Giggenhauser Str. 35 End of project: 30th September 2007
85354 Freising, Germany Project partners: 9
E-mail: roland.franz@ivv.fraunhofer.de Project costs: 2 351 712 Euro

Scientific Officer: Mrs. Dyanne Bennink, European Commission DG Research


E-mail: Dyanne.Bennink@cec.eu.int

IVV

Fraunhofer Institut
Verfahrenstechnik
und Verpackung
No. LOGO Partner
(01) FhG IVV Fraunhofer Institute for Process Engineering and
Packaging, Freising, DE
(02) DEFRA-CSL Central Science Laboratory, Dept. Food Environment &
Rural Affairs, York, GB
(03) FABES FABES Forschungs GmbH, München, DE
(04) PIRA Pira International, Leatherhead, GB
(05) EC-JRC-IHCP EC Joint Research Centre, Inst. Health and Consumer
Protection, Ispra, IT
(06) USDC University Santiago di Compostela, ES
(07) TUV IFCFT Vienna University of Technology, AT
(08) NESTLÉ RC Nestlé Research Centre, Lausanne, CH
(09) CEFIC-FCA European Chemical Industry Council, Food Contact
Additives Panel, Brussels, BE

IVV

Fraunhofer Institut
Verfahrenstechnik
und Verpackung
The basic equation to calculate FCM related exposure:

Exposure =
∑C ⋅P ⋅M
i i i via migration modelling

∑C n

where:
Ci = consumption rate of a particular food i
Pi = relative packaging usage of a given FCM for a particular food i
Mi = migration rate from a given FCM into a particular food i
n = number of foodstuffs considered for the exposure estimation

IVV

Fraunhofer Institut
Verfahrenstechnik
und Verpackung
.... was to develop an into-food migration model as
a novel and economic tool that may be applicable
in two different ways:
(1) As a stand alone tool to estimate exposure related migration
within the conventional frame conditions of the EU food regulatory
evaluation system thus applying a worst case exposure scenario,
i.e.:
Exposure = ∑ Mi
(2) In conjunction with statistical data obtained from food
consumption and plastics packaging surveys to estimate realistic
or worse-case exposure for any situation of interest,
i.e.:

Exposure =
∑C ⋅P ⋅M
i i i

∑C n

IVV

Fraunhofer Institut
Verfahrenstechnik
und Verpackung
WP 1: Sel. of Plastics & Migrants WP 2: Selection of Foods

WP 3: Physic.-Chemical Parameters WP 4: Phys.-Chem. Food


3a: Analytical methods in foods Specifications
3b: Migrations kinetics in foods
3c: Concentration profiles in foods

WP 7: Investigation
Attitude towards
of Consumer
Modelling
WP 5: Development, Verification &
Validation of the Migration Model

WP 6: Workability, Applicability & Validation


of the Migration Model

IVV

Fraunhofer Institut
Verfahrenstechnik
und Verpackung
.... for EU Commission and EFSA
In general:
Supporting present and future EU legislation for FCM

In particular:
- Scientific/technical basis for actualisation of
Directive 85/572/EEC issues
- Bringing more light into the dark related to meet
specific restrictions (SMLs) on the level of foodstuffs
- Supporting and plausibilisation of exposure
estimations
in context with petitions and setting specific
restrictions IVV

Fraunhofer Institut
Verfahrenstechnik
und Verpackung
.... for Industry
Packaging industry:
- Early (in the packaging development process) and food
type specific compliance evaluation
- Cost efficient compliance ensurance
Food industry:
- Improving or even establishing independent house-
internal quality assurance tools and this in a better
product specific way
- More knowledge about diffusion and partitioning
processes or organic compounds in foods
IVV

Fraunhofer Institut
Verfahrenstechnik
und Verpackung
.... for the Consumer
including ‘consumer protectors‘

- Better and more effective surveillance of FCM


- (Further) familiarisation with the idea of ‘Migration
Modelling‘ and increasing acceptance of calculated
migration values
- (Somewhat) cheaper packed foodstuffs?

And with the possible effect of ...


decreasing the FCM related conflict potential and
generating more confidence in FCM safety?
IVV

Fraunhofer Institut
Verfahrenstechnik
und Verpackung
IVV

Fraunhofer Institut
Verfahrenstechnik
und Verpackung

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