{"id":1646,"date":"2020-06-25T12:02:12","date_gmt":"2020-06-25T10:02:12","guid":{"rendered":"https:\/\/www.fabes-online.de\/bewertung\/"},"modified":"2026-02-24T12:42:31","modified_gmt":"2026-02-24T11:42:31","slug":"evaluation","status":"publish","type":"page","link":"https:\/\/www.fabes-online.de\/en\/evaluation\/","title":{"rendered":"Evaluation"},"content":{"rendered":"<p><\/p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container fusion-parallax-none hundred-percent-fullwidth non-hundred-percent-height-scrolling page-banner\" style=\"--awb-background-position:right center;--awb-background-position-small:right 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fusion-builder-row-4 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\"><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-2 awb-sticky awb-sticky-small awb-sticky-medium awb-sticky-large fusion_builder_column_1_4 1_4 fusion-flex-column fusion-flex-align-self-flex-start fusion-column-no-min-height fusion-no-small-visibility\" style=\"--awb-padding-top:45px;--awb-padding-right:20px;--awb-padding-bottom:20px;--awb-padding-left:20px;--awb-overflow:hidden;--awb-bg-color:#f1f4f8;--awb-bg-color-hover:#f1f4f8;--awb-bg-size:cover;--awb-border-radius:0px 0px 8px 8px;--awb-width-large:25%;--awb-margin-top-large:0px;--awb-spacing-right-large:0px;--awb-margin-bottom-large:20px;--awb-spacing-left-large:7.68%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;--awb-sticky-offset:70px;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\" style=\"--awb-content-alignment:left;\"><h3><strong>Contact<\/strong><\/h3>\n<\/div><ul style=\"--awb-iconcolor:#686868;--awb-line-height:27.2px;--awb-icon-width:27.2px;--awb-icon-height:27.2px;--awb-icon-margin:11.2px;--awb-content-margin:38.4px;\" class=\"fusion-checklist fusion-checklist-1 fusion-checklist-default fusion-checklist-divider type-icons\"><li class=\"fusion-li-item\" style><span class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-map-marker-alt fal\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p><strong>FABES For\u00adschungs-GmbH<\/strong><\/p>\n<p>for ana\u00adly\u00adtics and evaluation<br>\nof mass transfers<\/p>\n<p>Schra\u00adgen\u00adhof\u00adstr.&nbsp;35<br>\nD\u201180992 Munich<\/p>\n<\/div><\/li><li class=\"fusion-li-item\" style><span class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-phone-alt fal\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">+49 (0) 89 149009\u201350<\/div><\/li><li class=\"fusion-li-item\" style><span class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-fax fal\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">+49 (0) 89 149009\u201380<\/div><\/li><li class=\"fusion-li-item\" style><span class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-envelope-open-text fal\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\"><a style=\"color: #7d7d7d;\" href=\"mailto:info@fabes-online.de\">info@fabes-online.de<\/a><\/div><\/li><\/ul><\/div><\/div>\n<div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-3 fusion_builder_column_3_4 3_4 fusion-flex-column\" style=\"--awb-padding-top:45px;--awb-bg-size:cover;--awb-width-large:75%;--awb-margin-top-large:0px;--awb-spacing-right-large:2.56%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:2.56%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-2\"><h1><strong>Evaluation<\/strong><\/h1>\n<\/div><div class=\"fusion-text fusion-text-3\"><h2>EU\/ Germany: Food packaging materials<\/h2>\n<p>The migra\u00adti\u00adon of sub\u00ads\u00adtances from pack\u00ada\u00adging and other con\u00adsu\u00admer goods into fil\u00adling goods is strict\u00adly regu\u00adla\u00adted by law. Euro\u00adpean regu\u00adla\u00adti\u00adons, direc\u00adti\u00adves and reso\u00adlu\u00adti\u00adons as well as natio\u00adnal regu\u00adla\u00adti\u00adons and recom\u00admen\u00adda\u00adti\u00adons exist for this topic. For a more detail\u00aded expl\u00adana\u00adti\u00adon of the EU legis\u00adla\u00adti\u00adon, detail\u00aded gui\u00adde\u00adlines are available in some&nbsp;cases.<\/p>\n<p>For exam\u00adp\u00adle, Regu\u00adla\u00adti\u00adon (EC) No 1935\/2004 of the Euro\u00adpean Par\u00adlia\u00adment and of the Coun\u00adcil appli\u00ades to <u>all types of <\/u>mate\u00adri\u00adals and artic\u00adles inten\u00added to come into cont\u00adact with food sin\u00adce 27 Octo\u00adber 2004. Under Artic\u00adle 3 (1), the fol\u00adlo\u00adwing gene\u00adral requi\u00adre\u00adments are impo\u00adsed on all food packaging:<\/p>\n<p>Mate\u00adri\u00adals and artic\u00adles, inclu\u00adding acti\u00adve and intel\u00adli\u00adgent mate\u00adri\u00adals and artic\u00adles, shall be manu\u00adfac\u00adtu\u00adred in com\u00adpli\u00adance with good manu\u00adfac\u00adtu\u00adring prac\u00adti\u00adce so that, under nor\u00admal or fore\u00adseeable con\u00addi\u00adti\u00adons of use, they do not trans\u00adfer their con\u00adsti\u00adtu\u00adents to food in quan\u00adti\u00adties which&nbsp;could:<\/p>\n<p>[a] end\u00adan\u00adger human health; or<\/p>\n<p>[b] bring about an unac\u00adcep\u00adta\u00adble chan\u00adge in the com\u00adpo\u00adsi\u00adti\u00adon of the food;&nbsp;or<\/p>\n<p>[c] bring about a dete\u00adrio\u00adra\u00adti\u00adon in the orga\u00adno\u00adlep\u00adtic cha\u00adrac\u00adte\u00adristics thereof.<\/p>\n<p>Good manu\u00adfac\u00adtu\u00adring prac\u00adti\u00adce is regu\u00adla\u00adted in a very gene\u00adral way by Com\u00admis\u00adsi\u00adon Regu\u00adla\u00adti\u00adon (EC) No 2023\/2006.<\/p>\n<p>Artic\u00adle 5 of the Frame\u00adwork Regu\u00adla\u00adti\u00adon descri\u00adbes the groups defi\u00adned under ANNEX I to which this shall app\u00adly. Accor\u00adding to Artic\u00adle 6, this Regu\u00adla\u00adti\u00adon does not pre\u00advent Mem\u00adber Sta\u00adtes from main\u00adtai\u00adning or adop\u00adting natio\u00adnal pro\u00advi\u00adsi\u00adons in the absence of indi\u00advi\u00addu\u00adal mea\u00adsu\u00adres within the mea\u00adning of Artic\u00adle 5, pro\u00advi\u00added that they are in con\u00adfor\u00admi\u00adty with the pro\u00advi\u00adsi\u00adons of the Trea\u00adty. The recom\u00admen\u00adda\u00adti\u00adons of the Fede\u00adral Insti\u00adtu\u00adte for Risk Assess\u00adment (BfR) should be men\u00adtio\u00adned here as an example.<\/p>\n<p>The best regu\u00adla\u00adted food cont\u00adact mate\u00adri\u00adal is pla\u00ads\u00adtic mate\u00adri\u00adals, which must com\u00adply with the Com\u00admis\u00adsi\u00adon\u2019s Pla\u00ads\u00adtic Regu\u00adla\u00adti\u00adon (EU) No 10\/2011.<\/p>\n<p>In this Regu\u00adla\u00adti\u00adon, the fol\u00adlo\u00adwing dif\u00adfe\u00adrent pos\u00adsi\u00adbi\u00adli\u00adties of com\u00adpli\u00adance check are mentioned:<\/p>\n<ul>\n<li>Deter\u00admi\u00adna\u00adti\u00adon of over\u00adall migra\u00adti\u00adon under spe\u00adcial \u201cOM\u201d con\u00addi\u00adti\u00adons for com\u00adpli\u00adance with the over\u00adall migra\u00adti\u00adon limit (\u201cOML\u201d);<\/li>\n<li>Deter\u00admi\u00adna\u00adti\u00adon of spe\u00adci\u00adfic migra\u00adti\u00adon in food simu\u00adlants under \u201cSML\u201d con\u00addi\u00adti\u00adons to veri\u00adfy the sub\u00ads\u00adtance spe\u00adci\u00adfic migra\u00adti\u00adon limit (\u201cSML\u201d);<\/li>\n<li>Deter\u00admi\u00adna\u00adti\u00adon of resi\u00addu\u00adal con\u00adtent of the substance;<\/li>\n<li>Repla\u00adce\u00adment of spe\u00adci\u00adfic migra\u00adti\u00adon by over\u00adall migra\u00adti\u00adon, wher\u00adeby the migra\u00adti\u00adon con\u00addi\u00adti\u00adons must be identical;<\/li>\n<li>Assump\u00adti\u00adon of 100% migra\u00adti\u00adon of the sub\u00ads\u00adtance, based on the resi\u00addu\u00adal con\u00adtent of the sub\u00ads\u00adtance in the material;<\/li>\n<li>Mathe\u00adma\u00adti\u00adcal model\u00adling of migra\u00adti\u00adon using gene\u00adral\u00adly reco\u00adg\u00adnis\u00aded dif\u00adfu\u00adsi\u00adon models based on sci\u00aden\u00adti\u00adfic evi\u00addence, based on the resi\u00addu\u00adal con\u00adtent of the sub\u00ads\u00adtance in the material.<\/li>\n<\/ul>\n<p>To check com\u00adpli\u00adance, <strong>FABES<\/strong> exami\u00adnes migra\u00adti\u00adon from the pack\u00ada\u00adging into the fil\u00adling mate\u00adri\u00adal. For this pur\u00adpo\u00adse, so-cal\u00adled food simu\u00adlants are pre\u00adfer\u00ada\u00adb\u00adly used, simp\u00adle test media that mimic food and, through their beha\u00adviour, the migra\u00adti\u00adon from food cont\u00adact mate\u00adri\u00adals. Examp\u00adles are ace\u00adtic acid 3% for aci\u00addic foods and etha\u00adnol 50% for dairy pro\u00adducts. The cont\u00adact con\u00addi\u00adti\u00adons (time\/temperature) to be used in the test are spe\u00adci\u00adfi\u00adcal\u00adly pro\u00advi\u00added and repre\u00adsent quick tests with regard to the real cont\u00adact conditions.<\/p>\n<p>A test often includes the deter\u00admi\u00adna\u00adti\u00adon of total migra\u00adti\u00adons, scree\u00adnings for \u201cNIAS\u201d and, if neces\u00adsa\u00adry, spe\u00adci\u00adfic migra\u00adti\u00adons of sub\u00ads\u00adtances. Accor\u00adding to Regu\u00adla\u00adti\u00adon (EU) No 10\/2011, NIAS, \u2018non-inten\u00adtio\u00adnal\u00adly added sub\u00ads\u00adtances\u2019, means an impu\u00adri\u00adty in the sub\u00ads\u00adtances used or a reac\u00adtion inter\u00adme\u00addia\u00adte for\u00admed during the pro\u00adduc\u00adtion pro\u00adcess or a decom\u00adpo\u00adsi\u00adti\u00adon or reac\u00adtion pro\u00adduct. Fur\u00adther ana\u00adly\u00adses depend on the sam\u00adple struc\u00adtu\u00adre, the sam\u00adple matrix or the objec\u00adti\u00adve of the inves\u00adti\u00adga\u00adti\u00adon. An assess\u00adment is made on the basis of the ana\u00adly\u00adsed migra\u00adti\u00adon quan\u00adti\u00adties and cor\u00adre\u00adspon\u00adding posi\u00adti\u00adve lists (pla\u00ads\u00adtic: Uni\u00adon list), which list sub\u00ads\u00adtances who\u00adse use is part\u00adly only per\u00admit\u00adted with rest\u00adric\u00adtions. Under cer\u00adtain cir\u00adcum\u00ads\u00adtances, a fur\u00adther risk assess\u00adment is car\u00adri\u00aded&nbsp;out.<\/p>\n<p>The same pro\u00adce\u00addu\u00adre appli\u00ades to other con\u00adsu\u00admer goods such as&nbsp; phar\u00admaceu\u00adti\u00adcal pack\u00ada\u00adging, in addi\u00adti\u00adon to paper, card\u00adboard and card\u00adboard mate\u00adri\u00adals. It is important to know or have an idea of the worst case cont\u00adact con\u00addi\u00adti\u00adons of the pack\u00ada\u00adging or cont\u00adact mate\u00adri\u00adal, as migra\u00adti\u00adon con\u00addi\u00adti\u00adons depend on&nbsp;this.<\/p>\n<p><strong>FABES<\/strong> exami\u00adnes the abo\u00adve-men\u00adtio\u00adned mate\u00adri\u00adals with regard to the cor\u00adre\u00adspon\u00adding regu\u00adla\u00adti\u00adons and pre\u00adpa\u00adres the cer\u00adti\u00adfi\u00adca\u00adtes of con\u00adfor\u00admi\u00adty with regard to migra\u00adti\u00adon behaviour.<\/p>\n<p>In the case of <strong>recy\u00adcled mate\u00adri\u00adals<\/strong>, Regu\u00adla\u00adti\u00adon (EU) 2022\/1616 on recy\u00adcled pla\u00ads\u00adtic mate\u00adri\u00adals and artic\u00adles inten\u00added to come into cont\u00adact with food appli\u00ades. This regu\u00adla\u00adti\u00adon replaces the pre\u00advious Pla\u00ads\u00adtic Recy\u00adcling Regu\u00adla\u00adti\u00adon (EC) No. 282\/2008 and does not app\u00adly to post-indus\u00adtri\u00adal recy\u00adcla\u00adtes (PIR), which are indus\u00adtri\u00adal was\u00adte and scrap mate\u00adri\u00adals gene\u00adra\u00adted during pro\u00adduc\u00adtion and have the\u00adr\u00ade\u00adfo\u00adre not yet come into cont\u00adact with any fil\u00adling mate\u00adri\u00adal.&nbsp;The neces\u00adsa\u00adry tests are lar\u00adge\u00adly the same as for vir\u00adgin mate\u00adri\u00adals. Depen\u00adding on the type of pla\u00ads\u00adtic, addi\u00adtio\u00adnal tests are car\u00adri\u00aded out to ana\u00adly\u00adse known degra\u00adda\u00adti\u00adon pro\u00adducts that may result from recycling.<\/p>\n<p>If you have the objec\u00adti\u00adve of pla\u00adcing a sub\u00ads\u00adtance on the Uni\u00adon list for pla\u00ads\u00adtic mate\u00adri\u00adals, <strong>FABES<\/strong> can deter\u00admi\u00adne the migra\u00adti\u00adon and the initi\u00adal or resi\u00addu\u00adal con\u00adtent accor\u00adding to the spe\u00adci\u00adfi\u00adca\u00adti\u00adons of the Euro\u00adpean \u201cNote for Gui\u00addance\u201d. All pos\u00adsi\u00adble impu\u00adri\u00adties and resul\u00adting degra\u00adda\u00adti\u00adon and reac\u00adtion pro\u00adducts of the sub\u00ads\u00adtance are also taken into account. In addi\u00adti\u00adon, in clo\u00adse coope\u00adra\u00adti\u00adon with you, it is pos\u00adsi\u00adble to com\u00adpi\u00adle the com\u00adple\u00adte dos\u00adsier, which is made available e.g. to the Euro\u00adpean Food Safe\u00adty Aut\u00adho\u00adri\u00adty (EFSA) for eva\u00adlua\u00adti\u00adon. In addi\u00adti\u00adon to the abo\u00adve-men\u00adtio\u00adned ana\u00adly\u00adses, the dos\u00adsier also includes the uni\u00adque iden\u00adti\u00adfi\u00adca\u00adti\u00adon of the sub\u00ads\u00adtance, phy\u00adsi\u00adco\u00adche\u00admi\u00adcal pro\u00adper\u00adties of the sub\u00ads\u00adtance, the use of the sub\u00ads\u00adtance, infor\u00adma\u00adti\u00adon on the aut\u00adho\u00adri\u00adsa\u00adti\u00adon of the sub\u00ads\u00adtance in other count\u00adries and toxi\u00adco\u00adlo\u00adgi\u00adcal studies.<\/p>\n<p>If sub\u00ads\u00adtances are to be aut\u00adho\u00adri\u00adsed that are to be used e.g. in coa\u00adtings or paper mate\u00adri\u00adals, a dos\u00adsier cor\u00adre\u00adspon\u00adding to the EFSA dos\u00adsier must be sub\u00admit\u00adted to&nbsp;BfR.<\/p>\n<\/div><div class=\"fusion-title title fusion-title-1 sep-underline sep-solid fusion-title-text fusion-title-size-two\"><h2 class=\"fusion-title-heading title-heading-left\" style=\"margin:0;\">EU: Cosmetic packaging<\/h2><\/div><div class=\"fusion-text fusion-text-4\"><p>Accor\u00adding to Euro\u00adpean Regu\u00adla\u00adti\u00adon (EC) 1223\/2009 on cos\u00adme\u00adtic pro\u00adducts, a safe\u00adty assess\u00adment cove\u00adring, among other things, the cos\u00adme\u00adtic pro\u00adduct and its pack\u00ada\u00adging is required.<\/p>\n<p>Accor\u00adding to Artic\u00adle 17, the unin\u00adten\u00adtio\u00adnal pre\u00adsence of small quan\u00adti\u00adties of a pro\u00adhi\u00adbi\u00adted sub\u00ads\u00adtance resul\u00adting from con\u00adta\u00admi\u00adna\u00adti\u00adon of natu\u00adral or syn\u00adthe\u00adtic ingre\u00addi\u00adents, the manu\u00adfac\u00adtu\u00adring pro\u00adcess, sto\u00adrage, migra\u00adti\u00adon from pack\u00ada\u00adging, and which can\u00adnot be tech\u00adni\u00adcal\u00adly avo\u00adided in good manu\u00adfac\u00adtu\u00adring prac\u00adti\u00adce, is pro\u00adhi\u00adbi\u00adted if it does not com\u00adply with Artic\u00adle&nbsp;3.<\/p>\n<p>Com\u00adpli\u00adance with the requi\u00adre\u00adments of the Regu\u00adla\u00adti\u00adon regar\u00adding the pack\u00ada\u00adging mate\u00adri\u00adal can be ensu\u00adred by means of migra\u00adti\u00adon ana\u00adly\u00adses, as are also car\u00adri\u00aded out for the test\u00ading of food pack\u00ada\u00adging, and fur\u00adther sup\u00adple\u00admen\u00adta\u00adry analyses.<\/p>\n<p>When using <strong>recy\u00adcled mate\u00adri\u00adals<\/strong>, the infor\u00adma\u00adti\u00adon in the Cos\u00adPa\u00adTox gui\u00adde\u00adlines is taken into account. A pro\u00adce\u00addu\u00adre modi\u00adfied by FABES, which offers you increased safe\u00adty, is car\u00adri\u00aded out if desired.<\/p>\n<\/div><div class=\"fusion-title title fusion-title-2 sep-underline sep-solid fusion-title-text fusion-title-size-two\"><h2 class=\"fusion-title-heading title-heading-left\" style=\"margin:0;\">Germany: Drinking water contact materials<\/h2><\/div><div class=\"fusion-text fusion-text-5\"><p>In Ger\u00adma\u00adny, the Fede\u00adral Envi\u00adron\u00adment Agen\u00adcy (UBA) is respon\u00adsi\u00adble for drin\u00adking water cont\u00adact mate\u00adri\u00adals. For a com\u00adpli\u00adance check of the mate\u00adri\u00adals, cor\u00adre\u00adspon\u00adding spe\u00adci\u00adfi\u00adca\u00adti\u00adons of the UBA must be taken into account. For exam\u00adp\u00adle, published eva\u00adlua\u00adti\u00adon cri\u00adte\u00adria docu\u00adments app\u00adly to pla\u00ads\u00adtics and other orga\u00adnic mate\u00adri\u00adals, ena\u00admel or cera\u00admics, metal and cement, and cor\u00adre\u00adspon\u00adding recom\u00admen\u00adda\u00adti\u00adons or gui\u00adde\u00adlines app\u00adly to elas\u00adto\u00admers or lubri\u00adcants, sili\u00adco\u00adnes or TPE materials.<\/p>\n<p>Of inte\u00adrest here is the De Mini\u00admis Gui\u00adde\u00adline for the assess\u00adment of orga\u00adnic mate\u00adri\u00adals, accor\u00adding to which toxi\u00adco\u00adlo\u00adgi\u00adcal detec\u00adtion is no lon\u00adger neces\u00adsa\u00adry for a migra\u00adti\u00adon of &lt;0.1 \u00b5g\/L drin\u00adking water if other defi\u00adned spe\u00adci\u00adfi\u00adca\u00adti\u00adons&nbsp;apply.<\/p>\n<p>If a sub\u00ads\u00adtance is not lis\u00adted in a posi\u00adti\u00adve list of a docu\u00adment or recom\u00admen\u00adda\u00adti\u00adon, an appli\u00adca\u00adti\u00adon for inclu\u00adsi\u00adon is pos\u00adsi\u00adble. In addi\u00adti\u00adon to toxi\u00adco\u00adlo\u00adgi\u00adcal tests, this appli\u00adca\u00adti\u00adon also con\u00adsists of migra\u00adti\u00adon deter\u00admi\u00adna\u00adti\u00adons or mathe\u00adma\u00adti\u00adcal esti\u00adma\u00adti\u00adons (model\u00adlings) as well as initi\u00adal or resi\u00addu\u00adal con\u00adtent determinations.<\/p>\n<p>If a sub\u00ads\u00adtance is lis\u00adted in the Euro\u00adpean Pla\u00ads\u00adtics Regu\u00adla\u00adti\u00adon (EU) No 10\/2011 or the 4MS \u201ccore list\u201d, it has to be veri\u00adfied that the limit value is not exceeded.<\/p>\n<p><strong>FABES<\/strong> can pro\u00advi\u00adde you with com\u00adpre\u00adhen\u00adsi\u00adve advice and ana\u00adly\u00adti\u00adcal sup\u00adport on the abo\u00adve points. An appli\u00adca\u00adti\u00adon for inclu\u00adsi\u00adon is also possible.<\/p>\n<\/div><div class=\"fusion-title title fusion-title-3 sep-underline sep-solid fusion-title-text fusion-title-size-two\"><h2 class=\"fusion-title-heading title-heading-left\" style=\"margin:0;\">USA: Packaging materials<\/h2><\/div><div class=\"fusion-text fusion-text-6\"><p>For food cont\u00adact mate\u00adri\u00adals that are to be tes\u00adted for com\u00adpli\u00adance, a dif\u00adfe\u00adren\u00adtia\u00adted approach appli\u00ades in the USA. Depen\u00adding on the ques\u00adti\u00adon, an FDA inves\u00adti\u00adga\u00adti\u00adon is based on for\u00admu\u00adla\u00adti\u00adon checks, abo\u00adve-men\u00adtio\u00adned migra\u00adti\u00adon exami\u00adna\u00adti\u00adons and\/or extra\u00adc\u00adtions (\u201cfinal tests\u201d), which are to be car\u00adri\u00aded out in accordance with the \u201cCode of Fede\u00adral Regu\u00adla\u00adti\u00adon (CFR) Title 21\u201d. If a for\u00admu\u00adla\u00adti\u00adon ingre\u00addi\u00adent is not lis\u00adted under 21 CFR 174\u2013186 or the GRAS \u201cNoti\u00adces\u201d or is con\u00adside\u00adred \u201cpri\u00ador sanc\u00adtion\u00aded\u201d, is not sub\u00adject to a TOR exemp\u00adti\u00adon or does not have a valid FCN, the\u00adre are in prin\u00adci\u00adple seve\u00adral possibilities:<\/p>\n<ul>\n<li>Con\u00adside\u00adra\u00adti\u00adon of the \u201cfunc\u00adtion\u00adal bar\u00adri\u00ader\u201d prin\u00adci\u00adple or \u201cgene\u00adral\u00adly reco\u00adg\u00adnis\u00aded as safe\u201d (GRAS) principle;<\/li>\n<li>Appli\u00adca\u00adti\u00adon of a \u201cThres\u00adhold of Regu\u00adla\u00adti\u00adon\u201d (TOR) to the Ame\u00adri\u00adcan aut\u00adho\u00adri\u00adty&nbsp;FDA;<\/li>\n<li>Pre\u00adpa\u00adra\u00adti\u00adon of a \u201cFood Cont\u00adact Noti\u00adfi\u00adca\u00adti\u00adon\u201d (FCN) for sub\u00admis\u00adsi\u00adon to the Ame\u00adri\u00adcan aut\u00adho\u00adri\u00adty FDA, describ\u00ading the area of appli\u00adca\u00adti\u00adon of the sub\u00ads\u00adtance, its ana\u00adly\u00adsis, migra\u00adti\u00adon and toxi\u00adci\u00adty. The food simu\u00adlants and migra\u00adti\u00adon con\u00addi\u00adti\u00adons to be used are spe\u00adci\u00adfi\u00adcal\u00adly descri\u00adbed in the FDA\u2019s \u201cGui\u00addance for Indus\u00adtry \u2013 Che\u00admis\u00adtry Recommendations\u201d.<\/li>\n<\/ul>\n<p><strong>FABES<\/strong> can pro\u00advi\u00adde you with com\u00adpre\u00adhen\u00adsi\u00adve advice on the abo\u00adve points, pro\u00advi\u00adde ana\u00adly\u00adti\u00adcal sup\u00adport and con\u00adfirm con\u00adfor\u00admi\u00adty whe\u00adre possible.<\/p>\n<\/div><div class=\"fusion-title title fusion-title-4 sep-underline sep-solid fusion-title-text fusion-title-size-two\"><h2 class=\"fusion-title-heading title-heading-left\" style=\"margin:0;\">Other states<\/h2><\/div><div class=\"fusion-text fusion-text-7\"><p>Other count\u00adries, such as Switz\u00ader\u00adland or Chi\u00adna, lean on the EU or FDA specifications.<\/p>\n<p><strong>FABES<\/strong> will be hap\u00adpy to sug\u00adgest a pos\u00adsi\u00adble cour\u00adse of action with the aim of being able to con\u00adfirm conformity.<\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":1534,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"100-width.php","meta":{"wp_typography_post_enhancements_disabled":false,"footnotes":""},"class_list":["post-1646","page","type-page","status-publish","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/www.fabes-online.de\/en\/wp-json\/wp\/v2\/pages\/1646","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.fabes-online.de\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.fabes-online.de\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.fabes-online.de\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.fabes-online.de\/en\/wp-json\/wp\/v2\/comments?post=1646"}],"version-history":[{"count":9,"href":"https:\/\/www.fabes-online.de\/en\/wp-json\/wp\/v2\/pages\/1646\/revisions"}],"predecessor-version":[{"id":2167,"href":"https:\/\/www.fabes-online.de\/en\/wp-json\/wp\/v2\/pages\/1646\/revisions\/2167"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.fabes-online.de\/en\/wp-json\/wp\/v2\/media\/1534"}],"wp:attachment":[{"href":"https:\/\/www.fabes-online.de\/en\/wp-json\/wp\/v2\/media?parent=1646"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}