SPECIFIC MIGRATION LIMITS Software (SML)

Prediction of Migration Rate of Species
from Packaging Materials to Packed Goods

Videos

SML GENERAL

SML WEBINAR DRINKING WATER

SML THE SET-OFF FUNCTION

SML GENERAL

SML WEBINAR DRINKING WATER

SML THE SET-OFF FUNCTION

SML General

Introduction

The software SML is a joint development of the Swiss Federal Food Safety and Veterinary Office (FSVO, Switzerland) and the company Advanced Kinetics and Technology Solutions AG (AKTS AG, Switzerland). It supports compliance and migration risk assessment with European and Swiss Legislation for materials coming into contact with food, cosmetics, pharmaceuticals or drinking water.
Single- and repeated use food contact materials such as food packaging and kitchen utensils, drinking bottles, food processing equipment are in focus of the food contact legislation. Generally, migration of the packing components into food, which is determined by the rate of the diffusion, will be reduced upon successive uses. However, in specific cases the migration may increase upon successive uses due to e.g. the hydrolysis as observed in the case of the migration of formaldehyde from articles produced from phenol-formaldehyde or melamine-formaldehyde resins. Therefore, migration from repeated use articles e.g. a food storage boxes, bowls or plates should be assessed in three successive contact periods, using a new portion of food simulant for each contact period. Conventionally the migration rate determined in the third migration experiments shall comply with the relevant specific migration limit.
Determination of the migration from a repeated use article is similar to the procedure applied for single use articles. However, establishing the right contact conditions of time and temperature as well as the actual surface to volume ratio may be more complex. More details can be found in the guidelines of the EU Commission and the Joint Research Center.
More complex procedures should be applied for plastic materials which are in contact with drinking water. In this case, the simulation of the migration rate has to follow the testing requirements given in DIN EN 12873-1 and 2 and the KTW Guideline of the German UBA (Umweltbundesamt).

SML Webinar drinking water

Repeated Use Function

Demonstration Video

You will find below, a video demonstrating the prediction with repeated use


Description

Single- and repeated use food contact materials such as food packaging and kitchen utensils, drinking bottles, food processing equipment, are in focus of the food contact legislation. Generally, migration of the packing components into food, which is determined by the rate of the diffusion, will be reduced upon successive uses. However, in specific cases the migration may increase upon successive uses due to e.g. the hydrolysis as observed in the case of the migration of formaldehyde from articles produced from phenol-formaldehyde or melamine-formaldehyde resins. Therefore, migration from repeated use articles e.g. a food storage boxes, bowls or plates should be assessed in three successive contact periods, using a new portion of food simulant for each contact period. Conventionally the migration rate found determined in the third migration experiments shall comply with the relevant specific migration limit. Determination of the migration from a repeated use article is similar to the procedure applied for single use articles. However, establishing the right contact conditions of time and temperature as well as the actual surface to volume ratio may be more complex. More details can be found in the guidelines of the EU Commission and the Joint Research Center :

EU-commission-guidelines

More complex procedures should be applied for plastic materials which are in contact with drinking water. In this case, the simulation of the migration rate has to follow the testing requirements given in DIN EN 12873-1 and 2 and the KTW Guideline of the German UBA :

  • cold water: 1 + 3 x 3 days
  • warm water: 1 + 3 x 1 + 3 + 3 x 1 days
  • hot water: 1 + 3 x 1 + 3 + 3 x 1 days

According to the above requirements the extended testing cycles up to 31 days by repeating the above 10 days-long test cycles are optional for single- but compulsory for multilayer materials. The above-mentioned test cycles are implemented as predefined cycles in the SML 6 software.

SML The set-off function

Set-Off Function

Demonstration Video

Please see below a webinar video about the set-off function :

Description

During production and processing food contact materials and articles are stored often on the reel or in the stack where the inner food contact layer of the material or article comes into contact with the outer layer of the next bearing respectively item, during which transfer of substances from the outer layer (e.g. printing ink) to the food contact layer (e.g. sealing layer) occurs. The set-off function is an inbuilt functionality which simulates migration on the role or in the stack during storage after which the material or article is brought into contact with food or food simulant and the specific migration is simulated according to the conditions of use or testing.

Example

Aluminum tubes, conical with a protective coating inside manufactured from authorized substances and a decorative printing outside manufactured from ‘permitted’ substances (based on risk assessment).

AKTS-SML Software AKTS-SML Software


Set-off during storage

The conical tubes are stored in the stack prior to filling during which set-off, i.e. transfer of substances from the decorative printing to the protective coating occurs :

AKTS-SML Software

Migration testing for compliance

‘Permitted’ substances may be identified in the migration solution after testing by filling due to set-off, despite the fact that direct migration from outside to inside through the material structure (in this example aluminum) is not possible.
AKTS-SML Software

Compliance assessment:

  • Food contact layer contamination depending on sample history;
  • Detectable migration of authorized and ‘permitted’ substances (based on risk assessment);
  • Must comply with Article 3 of the Framework Regulation (EC) N°1935/2004

Summary

Set-off must be considered if food contact materials or articles are stored on the reel or in the stack before filling. Due to set-off inbuilt functional barrier properties of material structures may be deceived. The extent of set-off for individual substances depends on their migration rates and relative solubility in the relevant layers (diffusion and partitioning) and is time and temperature dependent, i.e. depends on material history.

The set-off function implemented in the SML 5 software simulates both the set-off process occurring in multilayer materials or articles and the migration process after filling. Hence the SML 5 software will support you in evaluating specific migration issues, i.e. compliance assessment for authorized substances and/or risk assessment for “permitted” substances.