Presentation at IFT19 by Dr. Ziynet Boz, Ph.D on Food Packaging Migration Models and their reliability in safety validation

1. Food Packaging
Migration Models and
Their Reliability in
Safety Validation
Created by:
Ziynet Boz, Ph.D.
Packaging Technology and Research LLC.

2. Created by:
Migration Overview
 Migration mechanism in food-
packaging systems
 Several affecting factors
 Several packaging technologies,
conditions, food types
 Databases generated with food
simulants for compliance
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Migration
Temperature
Concentration
MW
Solubility
Time
Compositions
Partition
Coefficients
Surface/
Volume
Ratio
Contact
type
Mobility

3. Created by:
Why models?
• Experimental procedures are time-
intensive, costly
• Numerous combinations of packaging-
food-environment
• Risk assessment in decision-making
• Limited migration packaging design
• Lowering the additive diffusivity during
synthesis
• Monomers, antioxidants, stabilizers,
antimicrobials etc.
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4. Created by:
Regulatory Opinions on Models
 Current state of the models in compliance
• Accepted models for FCMs are oversimplified, deterministic, “worst case”
scenario
• Initial Conditions: uniform distributions, no-migrant in food
• Boundary Conditions: No interface resistance
• No spatial distribution after migration
• Total migration amount is constant (No reaction / generation)
• High solubility of migrant in food (Partition coefficient = 1)
 If result is lower than SML
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5. Created by:
Migration Models: Deterministic
 Diffusion: Fick’s Law
• Fick’s Second Law of Diffusion
• MW distribution, density, crystallinity, orientation, solubility,
migrant molecular size, shape, plasticization effect, Tg, Tm
 Diffusion coefficient 𝐷𝐴
𝑃
 Partition coefficient 𝐾𝑝
 Assumptions
• C0, food = 0 , migrant is homogenously distributed in Pkg
• Good approximation for single layer packages
• Overestimation ageing, long storage, low MW ->
Overestimation
• Absence of chemical reaction, loss (e.g. evaporation)
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𝜕𝐶𝐴
𝑃
𝜕𝑡
= 𝐷𝐴
𝑃
𝜕2 𝐶𝐴
𝑃
𝜕𝑥2
𝐾𝑝 =
𝐶𝐴
𝑃
(∞)
𝐶𝐴
𝐹
(∞)
𝛼 =
𝑀𝐴
𝐹
(∞)
𝑀𝐴
𝑃
(∞)
=
𝐶𝐴
𝐹
(∞)
𝐶𝐴
𝑃
(∞)
=
𝑉 𝐹
𝐾𝑝 𝑉 𝑃
If 𝛼>>1 & Kp < 1 -> 100% migration

6. Created by:
Migration Models: Deterministic
6
Bi>100
No Resistance
h is not
infinitive
Diffusion
coefficient
Interaction
effects
Swelling of the packaging materials -> Swelling layer
E.g. Olive oil into PP
(Poças, Oliveira, Oliveira, & Hogg, 2008)

7. Created by:
Migration Models: Empirical
 Disregarding underlying mechanism
behind coefficients
• Empirical equations for D: LDPE, HDPE, PP -> f(T, MW)
(Arrhenius-like)
• Partitioning, mass transfer, polymer morphology, shape/polarity
of the migrant are not considered
• Piringer Model to determine D with overestimated diffusion
(50% of the results)
• Underestimate the effect of temperature for high MW migrants
• Limm and Hollifield model for additive diffusion in polyolefins
(Arr. Type)
 Weibull model
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Piringer model

8. Created by:
Migration Models: Probabilistic
 Variability in migration model outputs as a result of the uncertainty in model inputs
 Mixed effect models with deterministic models
 Probability distribution of the diffusion coefficient using Molecular mass
 Distribution of outputs
 Monte Carlo sampling
 Fourier Amplitude Sensitivity Test (FAST)
 Latin hypercube sampling
 Capturing lack of knowledge
• Temperature fluctuations
• Time of contact
• Non-systematic errors
 Uoverall Migration = 2 mg/dm2 or 12 mg/kg

9. Created by:
Migration Models: Plastics
 Majority of the migration studies are
polyolefins
 Low partition coefficients with non-polar
simulants/foods due to Tg
 Lack of data on polymers glassy at their
temperature of use
 PET requires longer testing time
• Recent studies: Virgin layer migration barrier
 Adhesives, urethane polymers, repeated Pkg
use
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Hexanal Olive oil migration (Gavriil,
Kanavouras, & Coutelieris, 2018)

10. Created by:
Migration Models: Paper & Paperboard
 Inhomogeneous medium:
Heterogenous, porous, fiber-
based
 Solid products
adsorption/desorption
 Fickian diffusion seems to poorly
estimate low porosity low thickness
 Simulants: Tenax®, Propak®
 Weibull model provides good fit
 Phthalates
 Migrant volatility, polarity, affinity
impact
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(Poças, Oliveira, Pereira, Brandsch, & Hogg, 2011)

11. Created by:
Migration Models: Other materials
 Ceramic and printing inks
 Cadmium and lead migration from
ceramic into acid food simulants was
studied
• Time-temperature influence
• Fickian Diffusion
• 600 h & 130 days
• Ion exchange -> hydrolysis
© INSTITUTE OF FOOD TECHNOLOGISTS | ALL RIGHTS RESERVED11 (Dong, Lu, & Liu, 2015)

12. Created by:
Simulation Software
 MIGRATEST 2000/2001 Fabes GmbH, Germany
 AKTS SML by Advanced Kinetics Technology Solution, Switzerland
 SMEWISE (Simulation of Migration Experiments with Swelling Effect)
 MULTITEMP, MULTIWISE by Safe Food Packaging Portal
 SFPP3 France
 FMECAengine
 FACET (Flavors, Additives and Food Contact Materials Exposure
Task)
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13. Created by:
Decision-making Based on Models
 FDA Model, EU Piringer model -> Overestimation 95%
• E.g. HDPE-food simulant, PET-water, AO-Tenax®, Photoinitiator-paper-Tenax®
 Oversimplification and assumptions: Over- or under-estimated
migration
 Possibility of rejecting potentially safe materials and chemicals
 Trained professionals
 Only for known chemicals IAS
 Target group: Converters and Chemical Industry
 High-throughput models only suitable for multiple migrants
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14. Created by:
Research Gaps
 A more realistic estimation of diffusion coefficients are needed
 Effects of swelling phenomenon
 Environment-package-food systems should be considered
 Data needed beyond regulatory compliance but a food quality perspective
 Actual interactions should be considered E.g. Oxygen effects, Flavor desorption
etc.
 Models of migrants from multilayer materials with numerical methods
 Industrial tools to assess the migration: Practical, Robust
 Non-plastic materials: E.g. paper and paperboard
 Nanomaterial migration assessment
 Emerging modeling methods E.g. Molecular modeling, molecular
thermodynamics, coupled models with human exposure
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15. Created by:
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