Modelling migration from plastics

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1 Modelling Migration from Plastics into Foodstuffs as a Novel and Cost efficient Efficient tool Tool for Estimation of Consumer Exposure from Food Contact Materials e Freising CT Modelling migration from plastics into foodstuffs as a novel and cost for estimation of consumer exposure from food contact materials Roland Franz, Fraunhofer, GERMANY Starting date: 01/03/2003 European Commission

2 Modelling Migration from Plastics into Foodstuffs as a Novel and Cost Thank Efficient Tool you for Estimation all of Consumer Exposure from Food Contact Materials First of all: for e CT for your interest in our Project project specifications and for coming! Starting date: 01/03/2003 European Commission

3 Contents CT Why did we get into this project? Modelling Migration from Plastics into Foodstuffs as a Novel and Cost [or: Efficient Tool for Estimation of Consumer Exposure from Food Contact Materials Why was the project unavoidable?] e Intention & structure of the project Starting date: 01/03/2003 European Commission

4 Why the project? Modelling Migration from Plastics into Foodstuffs as a Novel and Cost simple Efficient and Tool for Estimation of Consumer Exposure from Food Contact Materials e CT Migration tests should be simple and reproducible and have therefore been carried out so far using in the first place Starting date: 01/03/2003 food simulants and not foodstuffs. European Commission

5 Why the project? Modelling Migration from Plastics into Foodstuffs as a Novel and Cost compliance Efficient Tool for Estimation of Consumer Exposure from Food Contact Materials e CT On the other hand: EU legislation foresees that for the concentration (migration) in food Starting date: 01/03/2003 crucial one compared to the is the crucial food simulant test. European Commission

6 Why the project? Modelling Migration from Plastics into Foodstuffs as a Novel and Cost should Efficient (must) Tool for beestimation based onof Consumer Exposure from Food Contact Materials e CT And: Exposure estimation or assessment the concentration (migration) in food Starting date: 01/03/2003 and not on migration values in food simulants. European Commission

7 Why the project? Modelling Migration from Plastics into Foodstuffs as a Novel and Cost a correlation Efficient Tool for Estimation of Consumer Exposure from Food Contact Materials e CT Consequently, correlation is needed between food simulants and foods which is the intention of EU Directive 85/572/EEC. Starting date: 01/03/2003 However, problems were getting more and more evident over the years... European Commission over the

8 Why the project? Food item RF Relative migration default measured Modelling Migration from Plastics into Foodstuffs as a Novel and Cost Chocolate Efficient spread Tool for X/3 Estimation 0.33 of up to 1 Chocolate X/5 0.2 up to 1 Consumer Exposure Salami from Food Contact X/4 Materials 0.25 up to 0.88 Cocoa powder X/5* 0.2 up to for instance Mayonnaise (low fat) X/ up to 0.83 Mayonnaise Project X/3 specifications 0.33 up to 0.80 with these examples: Peanuts X/5* 0.2 up to 0.52 (where Dr migration Roland Franz is Butter Contract: X/2 0.5 QLK1-CT up to 0.57 e Starting date: 01/03/2003 given as relative Process Cheese (low fat) X/3* 0.33 up to 0.19 Engineering and Packaging Whole milk Duration: (A) n.a. 36 months up to 0.27 values: Irish cream liqueur (C ) n.a. up to 0.45 food / olive oil) Flour (NT) 0 up to 0.42 Buiscuit (rich tea) European (NT) Commission 0 up to 0.58 (Source: EU Report EN) Bread (NT) 0 up to 0.08 CT

9 Why the project? CT Modelling Migration from Plastics into Foodstuffs More as a Novel and Cost recent Efficient Tool for examples Estimation of Consumer Exposure from Food Contact Materials e examples from the ITX crisis [photo initiator in printing inks transferred to food via set-off] revealed again weaknesses of the Starting date: 01/03/ /572/EC system European Commission

10 Why the project? CT ITX and Modelling EHDAB Migration from Plastics into Foodstuffs levels as in a Novel and Cost Efficient Tool for Estimation of cloudy Consumer drinks Exposure from Food Contact Materials (fruit juices/nectars nectars) e... with (Source: EFSA opinion - ITX on ITX and EHDAB in FCM, dated 7 December 2005) Starting products date: 01/03/2003 measured... altogether 45 products with found concentrations for ITX between 20 ppb and 250 ppb - EHDAB between 10 and 125 ppb 10 ppb and 125 European Commission

11 Why the project? CT ITX and Modelling EHDAB Migration from Plastics into Foodstuffs levels as in a Novel and Cost Efficient Tool for Estimation of clear Consumer drinks Exposure from Food Contact Materials (fruit juices/nectars nectars) e... and (Source: EFSA opinion on ITX and EHDAB in FCM, dated 7 December 2005) Starting date: 01/03/ altogether 17 products measured and in all cases found concentrations were not detectable,, i.e < 5 ppb European Commission

12 Why the project? CT ITX and Modelling EHDAB Migration from Plastics into Foodstuffs levels as in a Novel and Cost Efficient Tool for Estimation of milk and Consumer soy Exposure from Food Contact Materials beverages e It (Source: EFSA opinion 10% on ITX and EHDAB in FCM, dated 7 December 2005) Starting date: 01/03/2003 It should be noted that water and 10% ethanol would give not detectables (< 5ppb) European (< Commission 5ppb)

13 Why the project?... enormous progress has been made in migration for mono- with food simulants, but also for multi-layer layer plastics. Further Modelling Migration over from the Plastics decade into Foodstuffs in advantageous as a Novel and Cost modelling, Efficient Tool, in particular for Estimation for of circumstances Consumer Exposure plastics from Food in contact Contact with Materials were that... e made CT essential developments have been made in the Starting area date: of certified 01/03/2003 or certifiable reference plastics films in relation to migration relevant specifications. European Commission

14 Modelling Migration from Plastics into Foodstuffs as a Novel and Cost Efficient Tool for Estimation of Consumer Exposure from Food Contact Materials e, Starting date: 1 st January 2003 Duration: 43 months End of project: 30 th September 2007 Project partners: 9 Project costs: Euro Mrs. Dyanne Bennink, European Commission Dyanne.Bennink@cec.eu.int

15 No. LOGO Partner (01) FhG e 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

16 The basic equation to calculate FCM related exposure: Exposure = C i P i C M n i via migration modelling where: C i = consumption rate of a particular food i P i = relative packaging usage of a given FCM for a particular food i M i = migration rate from a given FCM into a particular food i n = number of foodstuffs considered for the exposure estimation

17 ... 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 = M i (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 i Pi C M n i

18 WP 1: Sel. of Plastics & Migrants WP 2: Selection of Foods WP 3: Physic.-Chemical Parameters 3a: Analytical methods in foods 3b: Migrations kinetics in foods 3c: Concentration profiles in foods WP 5: Development, Verification & Validation of the Migration Model WP 6: Workability, Applicability & Validation of the Migration Model WP 4: Phys.-Chem. Food Specifications WP 7: Investigation of Consumer Attitude towards Modelling

19 ... for EU Commission and EFSA In general: Supporting present and future EU legislation for FCM In particular: - Scientific/technical 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

20 ... 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

21 ... 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?

22

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