Contact

  • FABES For­schungs-GmbH

    for ana­ly­tics and evaluation
    of mass transfers

    Schra­gen­hof­str. 35
    D‑80992 Munich

  • +49 (0) 89 149009–50
  • +49 (0) 89 149009–80
  • info@fabes-online.de

Software

Software programs can provide valuable services in compliance work. However, our programs also show their strength when a problem can no longer be solved analytically!

A few examp­les that FABES has been able to model in various pro­jects are inten­ded to show what pos­si­bi­li­ties for esti­ma­ti­on alre­a­dy exist:

  • Migra­ti­on (“sin­gle use” and “repea­ted use”) of a sub­s­tance from mono­lay­er and mul­ti­lay­er pla­s­tic pack­a­ging or paper pack­a­ging; objec­ti­ve: e.g. to con­firm migra­ti­on limits;
  • Migra­ti­on of a sub­s­tance from a drin­king water pipe mate­ri­al into (non-) flowing water (“sin­gle use” and “repea­ted use”). KTW gui­de­line and DIN EN 12873–1:2014 can be taken into account; aim: among others, to con­firm migra­ti­on limits;
  • Migra­ti­on of a sub­s­tance from a pla­s­tic mate­ri­al embedded in con­cre­te; objec­ti­ve: con­fir­ma­ti­on of migra­ti­on limits;
  • Migra­ti­on of a sub­s­tance from pla­s­tic pipes, roof tiles, win­dow frames or recy­cled pla­s­tics in rain­wa­ter; aim: esti­ma­ti­on of envi­ron­men­tal impact;
  • Acci­dent migra­ti­on ana­ly­sis: a trans­por­ter with a loa­ded “hazar­dous sub­s­tance” has an acci­dent, wher­eby the trans­por­ted goods fall into a near­by body of water; objec­ti­ve: esti­ma­ti­on of the envi­ron­men­tal impact;
  • Migra­ti­on of a sub­s­tance from a gar­ment (incl. fur­ther risk assess­ment for wea­ring the gar­ment – con­side­ra­ti­on of a film of sweat or sun­tan lotion on the skin); aim: esti­ma­ti­on of exposure;
  • Model­ling of the per­me­a­ti­on of gases by spe­cial matri­ces using the exam­p­le of a mem­bra­ne for regu­la­tors used in breathing appa­ra­tus for the fire brigade.

Do you have a spe­ci­fic pro­blem, but can’t find it in our pre­sen­ted solu­ti­ons? Then plea­se cont­act us. We may alre­a­dy have a pro­gram rea­dy that we can use for you! In prin­ci­ple, it is also pos­si­ble to deve­lop a new pro­gram tail­o­red to you in order to assess the migra­ti­on in the sys­tem “mate­ri­al – cont­act medium”.

It has been sci­en­ti­fi­cal­ly pro­ven that the migra­ti­on of sub­s­tances such as addi­ti­ves, slip agents, oli­go­mers, resi­du­al mono­mers, sta­bi­li­sers, pho­to­in­itia­tors, pla­s­ti­cisers, etc. from pla­s­tic mate­ri­als as well as from paper and card­board into dif­fe­rent cont­act media, e.g. food, drin­king water, air or soil, can be cal­cu­la­ted with sui­ta­ble theo­re­ti­cal models. Basi­cal­ly, each model is based on the solu­ti­on of spe­ci­fic mathe­ma­ti­cal equa­tions taking into account migra­ti­on con­di­ti­ons (time/temperature) and the input of data and para­me­ters reflec­ting the natu­re of the cont­act mate­ri­al-cont­act medi­um system.

For the food pack­a­ging sec­tor, it was alre­a­dy sti­pu­la­ted in the EU Pla­s­tics Direc­ti­ve 2002/72/EC that com­pli­ance with spe­ci­fic migra­ti­on limits (SMLs) can be tes­ted and pro­ven by app­ly­ing sci­en­ti­fi­cal­ly reco­g­nis­ed dif­fu­si­on models. This was taken over in the Euro­pean Pla­s­tics Regu­la­ti­on (EU) No 10/2011 Annex V, §2.2.3 and expan­ded in con­tent. A detail­ed “Prac­ti­cal Gui­de­line” docu­ment on this Annex, which pro­vi­des detail­ed help and gui­dance on in which cases and in which way migra­ti­on model­ling has to be per­for­med for the com­pli­ance test of a pla­s­tic food pack­a­ging, was published in 2015 by JRC-Ispra in coope­ra­ti­on with the EU Commission.

The FDA is also awa­re of the bene­fits of such pro­grams, which is why it allows the use of soft­ware pro­grams for esti­mat­ing migra­ti­ons in accordance with the “Gui­dance for Indus­try – Pre­pa­ra­ti­on of Pre­mar­ket Sub­mis­si­ons for Food Cont­act Sub­s­tances: Che­mis­try Recommendations”.

FABES had essen­ti­al­ly par­ti­ci­pa­ted in the ear­ly stages of the con­sul­ta­ti­ons and work that led to the­se legal requi­re­ments. Under the coor­di­na­ti­on of Dr Pirin­ger, the sci­en­ti­fic basis and data for the migra­ti­on esti­ma­ti­on within the frame­work of the Pla­s­tics Direc­ti­ve 2002/72/EC were ela­bo­ra­ted around the turn of the mill­en­ni­um. At the same time, the user-fri­end­ly soft­ware MIGRATEST© LITE was deve­lo­ped at FABES, which enab­led users to cal­cu­la­te migra­ti­on from mono­lay­er pla­s­tic mate­ri­als and use it for com­pli­ance test­ing, as recom­men­ded by the afo­re­men­tio­ned direc­ti­ve. FABES was invol­ved as a con­sul­ting expert in the pre­pa­ra­ti­on of the abo­ve-men­tio­ned “Prac­ti­cal Gui­de­line” document.

In addi­ti­on, FABES deve­lo­ped the user-fri­end­ly com­mer­cial soft­ware MIGRATEST© EXP more than 10 years ago. This pro­gram enables the esti­ma­ti­on of the migra­ti­on of sub­s­tances from both mono- and mul­ti­lay­er pack­a­ging into real food and food simu­lants – “set-off” effects can be taken into account.

The esti­ma­ti­on of migra­ti­on when pla­s­tics come into cont­act with drin­king water was reco­g­nis­ed as a test method by the Ger­man Fede­ral Envi­ron­ment Agen­cy (UBA) within the frame­work of the “Gui­de­line for the mathe­ma­ti­cal esti­ma­ti­on of migra­ti­on of indi­vi­du­al sub­s­tances from orga­nic mate­ri­als into drin­king water (model­ling gui­de­line)” – Octo­ber 2008. FABES was invol­ved in the con­sul­ta­ti­ons and work that led to the draf­ting and adop­ti­on of this gui­de­line. In con­nec­tion with this gui­de­line, the soft­ware MIGRAPIPE© was deve­lo­ped at FABES. Curr­ent­ly, FABES is invol­ved in the revi­si­on of the abo­ve gui­de­line with the aim of brin­ging this docu­ment up to date with the cur­rent sta­te of know­ledge and at the same time making it a prac­ti­cal refe­rence for the user of migra­ti­on model­ling in drin­king water.

Sub­s­tances used in indus­try that may end­an­ger human health or the envi­ron­ment are the main sub­ject of Regu­la­ti­on (EC) No 1907/2006 (REACH Regu­la­ti­on). In this con­text, the migra­ti­on of such sub­s­tances from pla­s­tics and other mate­ri­als in various indus­tri­al cont­act media (soil, tech­no­lo­gi­cal liquids, cir­cu­la­ting air, etc.) or into the human body is also an important aspect. Such migra­ti­on pro­ces­ses can also be theo­re­ti­cal­ly esti­ma­ted with sui­ta­ble models. In the short descrip­ti­ons of MIGRATEST© XTR, MIGRATEST© SKN and MIGRATEST© SPH you will learn more.

At FABES, soft­ware pro­grams have also been deve­lo­ped in recent years that enable migra­ti­on cal­cu­la­ti­ons for sce­na­ri­os that are not deri­ved from a legal spe­ci­fi­ca­ti­on (regu­la­ti­on, direc­ti­ve, recom­men­da­ti­on of gui­de­line). The­se soft­ware pro­grams ser­ve rese­arch and deve­lo­p­ment tasks in par­ti­cu­lar or can be used to sol­ve very spe­ci­fic migra­ti­on pro­blems. The­se are the soft­ware pro­grams MIGRATEST© RU, MIGR-DISTRIBUTION, SIMAQUA F and MIGRATEST© DDX. Fur­ther infor­ma­ti­on can be found in their short descriptions.

Cont­act us and bene­fit from the in-depth know­ledge of the FABES team and our com­pre­hen­si­ve databases.