• 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


EU/ Germany: Packaging materials

The migra­ti­on of sub­s­tances from pack­a­ging and other con­su­mer goods into fil­ling goods is strict­ly regu­la­ted by law. Euro­pean regu­la­ti­ons, direc­ti­ves and reso­lu­ti­ons as well as natio­nal regu­la­ti­ons and recom­men­da­ti­ons exist for this topic. For a more detail­ed expl­ana­ti­on of the EU legis­la­ti­on, detail­ed gui­de­lines are available in some cases.

For exam­p­le, Regu­la­ti­on (EC) No 1935/2004 of the Euro­pean Par­lia­ment and of the Coun­cil appli­es to all types of mate­ri­als and artic­les inten­ded to come into cont­act with food sin­ce 27 Octo­ber 2004. Under Artic­le 3 (1), the fol­lo­wing gene­ral requi­re­ments are impo­sed on all food packaging:

Mate­ri­als and artic­les, inclu­ding acti­ve and intel­li­gent mate­ri­als and artic­les, shall be manu­fac­tu­red in com­pli­ance with good manu­fac­tu­ring prac­ti­ce so that, under nor­mal or fore­seeable con­di­ti­ons of use, they do not trans­fer their con­sti­tu­ents to food in quan­ti­ties which could:

[a] end­an­ger human health; or

[b] bring about an unac­cep­ta­ble chan­ge in the com­po­si­ti­on of the food; or

[c] bring about a dete­rio­ra­ti­on in the orga­no­lep­tic cha­rac­te­ristics thereof.

Good manu­fac­tu­ring prac­ti­ce is regu­la­ted in a very gene­ral way by Com­mis­si­on Regu­la­ti­on (EC) No 2023/2006.

Artic­le 5 of the Frame­work Regu­la­ti­on descri­bes the groups defi­ned under ANNEX I to which this shall app­ly. Accor­ding to Artic­le 6, this Regu­la­ti­on does not pre­vent Mem­ber Sta­tes from main­tai­ning or adop­ting natio­nal pro­vi­si­ons in the absence of indi­vi­du­al mea­su­res within the mea­ning of Artic­le 5, pro­vi­ded that they are in con­for­mi­ty with the pro­vi­si­ons of the Trea­ty. The recom­men­da­ti­ons of the Fede­ral Insti­tu­te for Risk Assess­ment (BfR) should be men­tio­ned here as an example.

The best regu­la­ted food cont­act mate­ri­al is pla­s­tic mate­ri­als, which must com­ply with the Commission’s Pla­s­tic Regu­la­ti­on (EU) No 10/2011.

In this Regu­la­ti­on, the fol­lo­wing dif­fe­rent pos­si­bi­li­ties of com­pli­ance check are mentioned:

  • Deter­mi­na­ti­on of over­all migra­ti­on under spe­cial “OM” con­di­ti­ons for com­pli­ance with the over­all migra­ti­on limit (“OML”);
  • Deter­mi­na­ti­on of spe­ci­fic migra­ti­on in food simu­lants under “SML” con­di­ti­ons to veri­fy the sub­s­tance spe­ci­fic migra­ti­on limit (“SML”);
  • Deter­mi­na­ti­on of resi­du­al con­tent of the substance;
  • Repla­ce­ment of spe­ci­fic migra­ti­on by over­all migra­ti­on, wher­eby the migra­ti­on con­di­ti­ons must be identical;
  • Assump­ti­on of 100% migra­ti­on of the sub­s­tance, based on the resi­du­al con­tent of the sub­s­tance in the material;
  • Mathe­ma­ti­cal model­ling of migra­ti­on using gene­ral­ly reco­g­nis­ed dif­fu­si­on models based on sci­en­ti­fic evi­dence, based on the resi­du­al con­tent of the sub­s­tance in the material.

To check com­pli­ance, FABES exami­nes migra­ti­on from the pack­a­ging into the fil­ling mate­ri­al. For this pur­po­se, so-cal­led food simu­lants are pre­fer­a­b­ly used, simp­le test media that mimic food and, through their beha­viour, the migra­ti­on from food cont­act mate­ri­als. Examp­les are ace­tic acid 3% for aci­dic foods and etha­nol 50% for dairy pro­ducts. The cont­act con­di­ti­ons (time/temperature) to be used in the test are spe­ci­fi­cal­ly pro­vi­ded and repre­sent quick tests with regard to the real cont­act conditions.

A test often includes the deter­mi­na­ti­on of total migra­ti­ons, scree­nings for “NIAS” and, if neces­sa­ry, spe­ci­fic migra­ti­ons of sub­s­tances. Accor­ding to Regu­la­ti­on (EU) No 10/2011, NIAS, ‘non-inten­tio­nal­ly added sub­s­tances’, means an impu­ri­ty in the sub­s­tances used or a reac­tion inter­me­dia­te for­med during the pro­duc­tion pro­cess or a decom­po­si­ti­on or reac­tion pro­duct. Fur­ther ana­ly­ses depend on the sam­ple struc­tu­re, the sam­ple matrix or the objec­ti­ve of the inves­ti­ga­ti­on. An assess­ment is made on the basis of the ana­ly­sed migra­ti­on quan­ti­ties and cor­re­spon­ding posi­ti­ve lists (pla­s­tic: Uni­on list), which list sub­s­tances who­se use is part­ly only per­mit­ted with rest­ric­tions. Under cer­tain cir­cum­s­tances, a fur­ther risk assess­ment is car­ri­ed out.

The same pro­ce­du­re appli­es to other con­su­mer goods such as cos­me­tic or phar­maceu­ti­cal pack­a­ging, in addi­ti­on to paper, card­board and card­board mate­ri­als. It is important to know or have an idea of the worst case cont­act con­di­ti­ons of the pack­a­ging or cont­act mate­ri­al, as migra­ti­on con­di­ti­ons depend on this.

FABES exami­nes the abo­ve-men­tio­ned mate­ri­als with regard to the cor­re­spon­ding regu­la­ti­ons and pre­pa­res the cer­ti­fi­ca­tes of con­for­mi­ty with regard to migra­ti­on behaviour.

If you have the objec­ti­ve of pla­cing a sub­s­tance on the Uni­on list for pla­s­tic mate­ri­als, FABES can deter­mi­ne the migra­ti­on and the initi­al or resi­du­al con­tent accor­ding to the spe­ci­fi­ca­ti­ons of the Euro­pean “Note for Gui­dance”. All pos­si­ble impu­ri­ties and resul­ting degra­da­ti­on and reac­tion pro­ducts of the sub­s­tance are also taken into account. In addi­ti­on, in clo­se coope­ra­ti­on with you, it is pos­si­ble to com­pi­le the com­ple­te dos­sier, which is made available e.g. to the Euro­pean Food Safe­ty Aut­ho­ri­ty (EFSA) for eva­lua­ti­on. In addi­ti­on to the abo­ve-men­tio­ned ana­ly­ses, the dos­sier also includes the uni­que iden­ti­fi­ca­ti­on of the sub­s­tance, phy­si­co­che­mi­cal pro­per­ties of the sub­s­tance, the use of the sub­s­tance, infor­ma­ti­on on the aut­ho­ri­sa­ti­on of the sub­s­tance in other count­ries and toxi­co­lo­gi­cal studies.

If sub­s­tances are to be aut­ho­ri­sed that are to be used e.g. in coa­tings or paper mate­ri­als, a dos­sier cor­re­spon­ding to the EFSA dos­sier must be sub­mit­ted to BfR.

Germany: Drinking water contact materials

In Ger­ma­ny, the Fede­ral Envi­ron­ment Agen­cy (UBA) is respon­si­ble for drin­king water cont­act mate­ri­als. For a com­pli­ance check of the mate­ri­als, cor­re­spon­ding spe­ci­fi­ca­ti­ons of the UBA must be taken into account. For exam­p­le, published eva­lua­ti­on cri­te­ria docu­ments app­ly to pla­s­tics and other orga­nic mate­ri­als, ena­mel or cera­mics, metal and cement, and cor­re­spon­ding recom­men­da­ti­ons or gui­de­lines app­ly to elas­to­mers or lubri­cants, sili­co­nes or TPE materials.

Of inte­rest here is the De Mini­mis Gui­de­line for the assess­ment of orga­nic mate­ri­als, accor­ding to which toxi­co­lo­gi­cal detec­tion is no lon­ger neces­sa­ry for a migra­ti­on of <0.1 µg/L drin­king water if other defi­ned spe­ci­fi­ca­ti­ons apply.

If a sub­s­tance is not lis­ted in a posi­ti­ve list of a docu­ment or recom­men­da­ti­on, an appli­ca­ti­on for inclu­si­on is pos­si­ble. In addi­ti­on to toxi­co­lo­gi­cal tests, this appli­ca­ti­on also con­sists of migra­ti­on deter­mi­na­ti­ons or mathe­ma­ti­cal esti­ma­ti­ons (model­lings) as well as initi­al or resi­du­al con­tent determinations.

If a sub­s­tance is lis­ted in the Euro­pean Pla­s­tics Regu­la­ti­on (EU) No 10/2011 or the 4MS “core list”, it has to be veri­fied that the limit value is not exceeded.

FABES can pro­vi­de you with com­pre­hen­si­ve advice and ana­ly­ti­cal sup­port on the abo­ve points. An appli­ca­ti­on for inclu­si­on is also possible.

USA: Packaging materials

For food cont­act mate­ri­als that are to be tes­ted for com­pli­ance, a dif­fe­ren­tia­ted approach appli­es in the USA. Depen­ding on the ques­ti­on, an FDA inves­ti­ga­ti­on is based on for­mu­la­ti­on checks, abo­ve-men­tio­ned migra­ti­on exami­na­ti­ons and/or extra­c­tions (“final tests”), which are to be car­ri­ed out in accordance with the “Code of Fede­ral Regu­la­ti­on (CFR) Title 21”. If a for­mu­la­ti­on ingre­di­ent is not lis­ted under 21 CFR 174–186 or the GRAS “Noti­ces” or is con­side­red “pri­or sanc­tion­ed”, is not sub­ject to a TOR exemp­ti­on or does not have a valid FCN, the­re are in prin­ci­ple seve­ral possibilities:

  • Con­side­ra­ti­on of the “func­tion­al bar­ri­er” prin­ci­ple or “gene­ral­ly reco­g­nis­ed as safe” (GRAS) principle;
  • Appli­ca­ti­on of a “Thres­hold of Regu­la­ti­on” (TOR) to the Ame­ri­can aut­ho­ri­ty FDA;
  • Pre­pa­ra­ti­on of a “Food Cont­act Noti­fi­ca­ti­on” (FCN) for sub­mis­si­on to the Ame­ri­can aut­ho­ri­ty FDA, describ­ing the area of appli­ca­ti­on of the sub­s­tance, its ana­ly­sis, migra­ti­on and toxi­ci­ty. The food simu­lants and migra­ti­on con­di­ti­ons to be used are spe­ci­fi­cal­ly descri­bed in the FDA’s “Gui­dance for Indus­try – Che­mis­try Recommendations”.

FABES can pro­vi­de you with com­pre­hen­si­ve advice on the abo­ve points, pro­vi­de ana­ly­ti­cal sup­port and con­firm con­for­mi­ty whe­re possible.

Other states

Other count­ries, such as Switz­er­land or Chi­na, lean on the EU or FDA specifications.

FABES will be hap­py to sug­gest a pos­si­ble cour­se of action with the aim of being able to con­firm conformity.