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The program SML is a joint development of the Swiss Federal Food Safety and Veterinary Office (FSVO, Switzerland), the company Advanced Kinetics and Technology Solutions AG (AKTS AG, Switzerland) and MDCTec Systems GmbH (Germany). It supports compliance and migration risk assessment of materials coming into contact with food, cosmetics, pharmaceuticals or drinking water with European and Swiss Legislation. The verification of compliance with specific migration limits (SML) of food contact materials and articles by the application of generally recognized diffusion models based on scientific evidence is included in the European legislation since more than 10 years.
Safety evaluation of plastics materials and articles with respect to other applications like toys, automotive, construction, etc. is supported as well.
For more information about AKTS-SML Software, please see http://www.akts.com/sml.html
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Set-Off Function - Application notes
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.
Please see below a webinar video about the set-off function:
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).
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:
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.
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.
Yours sincerely,
AKTS AG - MDCTec Systems GmbH
AKTS AG
Advanced Kinetics
& Technology Solutions
TECHNOArk 1
3960 Siders
Switzerland |
MDCTec Systems GmbH
Im Martinipark
Provinostr. 52
86153 Augsburg
Germany
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Federal Departement of Home Affairs FDHA
Federal Food Safety and Veterinary Office FSVO
Schwarzenburgstrasse 155
3003 Bern
Switzerland
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SML: http://www.akts.com/sml.html
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