AKTS SML

Specific migration assessment for complex materials

Features

  • Locating Contaminant Migration Events

  • Exact assessment of migration processes

  • Simplified packaging design

  • Check compliance with compliance guidelines

The SML program is a joint development of the Federal Food Safety and Veterinary Office (FSVO, Switzerland), Advanced Kinetics and Technology Solutions AG (AKTS AG, Switzerland) and MDCTec Systems GmbH (Germany).

Verification of food packaging compliance through the application of accepted diffusion models has been introduced in recent European legislation.

The use of advanced Finite Element Analysis (FEA) migration modeling with the SML software [1] predicts the amount of migration of organic matter such as residual monomers, additives, impurities, reaction products, non-intentionally added substances from multilayer or multi-layered multi-material materials the packaged food or other contact media such as pharmaceuticals, cosmetics, drinking water or the environment.

The presented method ensures compliance with plastic contact materials and articles with specific migration limits according to EU Regulations [/ fusion_popover] and Swiss Legislation [/ fusion_popover]. The technique allows specific migration evaluation for complex materials, eg different geometries and multi-layered structures.

The simulation of the migration process is based on Ficks 2nd law of diffusion taking into account the partitioning between adjacent layers or contact media in closed systems [1-4]. The temperature dependence of the diffusion process is considered by the Arrhenius equation. Diffusion coefficients of substances in the polymer are estimated by generally accepted estimation methods, such as the Piringer model based on polymer-specific constants (AP values) [2], which are available for a limited number of polymers.

The extension of the AP value model by Brandsch [5] for the estimation of diffusion coefficients based on the glass transition temperature of polymers opens up modeling possibilities for any polymer or polymer mixture characterized by a glass transition temperature. The estimation of the separation coefficients between contact layer and contact medium (eg polymer and food simulant or water) is based on the polarity of the migrants, expressed by the octanol / water partition coefficient of the substances [6]. Time-dependent migration curves and the concentration profile within all layers of multilayer structures can be calculated for both migrants from the material and from the contact medium. It is possible to simulate the release of materials from multilayer materials in extended temperature ranges and under temperature conditions where the experimental investigation would be very difficult, eg if the temperature fluctuates during the observation period. Complex ambient temperature profiles can be considered as gradual, modulated, shock and additionally for temperature profiles that reflect real atmospheric temperature changes (annual temperature profiles of different climates with daily minimum and maximum fluctuations).

 

[2] C. Simoneau, ed., “Application of generally recognizable diffusion models for the estimation of specific migration in support of EU Directive 2002/72 / EC”, JRC Scientific and Technical Reports, 2010[3] EU, 2011, European Commission Regulation (EU) No 10/2011 relating to plastic materials and articles intended to come into contact with foodstuffs. Official Journal of the European Union 15.1.2011; L 12/1[4] EDI Ordinance on Commodities of 23 November 2005 (as at 1 May 2011); http://www.bag.admin.ch[5] Asako Ozaki, Anita Gruner, Angela Störmer, Rainer Brandsch and Roland Franz; “Correlation between Partition Coefficients Polymer / Food Simulant, KP, F, and Octanol / Water, Log POW – a New Approach to Supporting Migration Modeling and Compliance Testing”[6] Rainer Brandsch, to be published [/ fusion_toggle] [/ fusion_accordion]

NEW in SML 5:

  • Migration modeling for an entire packaging structure based on several articles (eg lid and tray)
  • Migration modeling for an unlimited number of levels
  • Migration modeling of an unlimited number of substances at once (batch process).
  • Probabilistic migration modeling and sensitivity analysis based on Gaussian distributions for all inputs with Monte Carlo, Sobol and FAST technique.
  • Estimation of separation coefficients between contact layer and contact medium (eg, polymer and food simulant or water) based on the polarity of migrants expressed by the octanol / water partition coefficient of the substance
  • EDI Decree on Commodities of 23 November 2005 (as at 1 May 2011); http://www.bag.admin.ch [4].
  • Extending the AP value model of Brandsch for the estimation of diffusion coefficients based on the glass transition temperature of polymers, which opens up the possibility of modeling any polymer or polymer mixture characterized by a glass transition temperature [5].
  • Brandsch’s proprietary estimation method for diffusional polymers in polymers based on the glass transition temperature of polymers and estimation of partition coefficients between polymers based on the solubility of substances in adjacent polymer layers.
  • Compliance assessment for specific migration limit substances (SMLs) listed in the Plastics Regulation (EU) No. 10/2011 and the preparation of compliance certificates.