Migration Limit UOM
Hi,
Can anyone here explain to me what are possible units of measurement for overall migration? EU uses mg/dm2 as UOM in their regulation, however, upon checking other standards in other countries, the Korean Ministry of Food and Drug Safety uses mg/L in their regulations. Can one UOM be converted into the other?
Generally yes, you can convert the units back and forth.
Hi,
Can anyone here explain to me what are possible units of measurement for overall migration? EU uses mg/dm2 as UOM in their regulation, however, upon checking other standards in other countries, the Korean Ministry of Food and Drug Safety uses mg/L in their regulations. Can one UOM be converted into the other?
A universally applicable direct conversion factor between area and volume sounds somewhat elusive.
I suspect there is some more context involved.
Generally yes, you can convert the units back and forth.
Hello,
I could've easily converted the units back and forth if the units of measurements have the same dimensions, however, one uses mg/dm2 (mass/area) while the other one is mg/L (mass/volume). That's why I was really confused with the UOM for overall migration.
A universally applicable direct conversion factor between area and volume sounds somewhat elusive.
I suspect there is some more context involved.
Yeah, I figured there should be something that I'm missing in the standards. I will get back to this post once I have the time to review the standards again. Thank you! :)
Hi prg_1993,
No direct conversion between area and volume. On the EC guidelines for migration limit, you can either use mass/area (Directive 2002/72/EC) or mass/volume as unit of measurement. See sample on Annex 1 of Commission Regulation (EC) No 1895/2005.
Regards.
Mandark
Seems to be a variety of offerings -
Migration limits have been set because plastics should not transfer their components into the foodstuff in unacceptable quantities. The transfer of constituents from food contact materials into food is called migration. To ensure protection of health of the consumer and to avoid any contamination of the foodstuff two types of migration limits have been established for plastic materials:
1. an Overall Migration Limit (OML) of 60 mg (of substances)/kg (of foodstuff or food simulants) or 10 mg/ dm2 (of surface area of material or article) applies to all substances that can migrate from food contact materials to foodstuffs;
2. a Specific Migration Limit (SML) which applies to individual authorized substances and is based on the toxicological evaluation (by European Food Safety Authority) of the substance.
For certain substances, a maximum permitted quantity of that substance, in the finished material or article, is admitted (called QM).
WP European legislation on food contact materials.pdf 1.2MB 25 downloads
(approx 2010)
@ Mandark - thks for ref. but i don't see any mention of volumes in the example Annex1
Hi prg_1993,
Looking at the korean regs, there appears to be a specified methodology as to how the migration tests are conducted, hence why they may have just indicated a final concentration rather than a surface area standard. My recommendation would be to get a hold of the test method they use and learn how it's conducted (which should include volume and surface area), and that will allow you to convert to the units you need.
Alternatively, it's possible that they only care about the final concentration of the migrant in the container under conditions of use, rather than the quality of the material itself, which would be a reasonable and more lenient risk management approach, in which case you would evaluate your products under the conditions of use with the values you have and see if it would be expected to cause a concentration increase in the final product.