{"id":7810,"date":"2025-10-14T09:00:00","date_gmt":"2025-10-14T08:00:00","guid":{"rendered":"https:\/\/uplastech.com\/food-grade-silicone\/"},"modified":"2026-10-28T09:22:40","modified_gmt":"2026-10-28T09:22:40","slug":"food-grade-silicone","status":"publish","type":"post","link":"https:\/\/uplastech.com\/ja\/food-grade-silicone\/","title":{"rendered":"Food-Grade Silicone: What the Certification Actually Covers"},"content":{"rendered":"<style>\n.upl-blog{font-size:17px;line-height:1.78;color:#1f2937}\n.upl-blog p{margin:0 0 18px}\n.upl-blog h2{font-size:26px;line-height:1.3;color:#0b2b33;margin:46px 0 14px;font-weight:700;letter-spacing:-.015em}\n.upl-blog h3{font-size:19.5px;color:#0d3b47;margin:28px 0 10px;font-weight:700}\n.upl-blog ul,.upl-blog ol{margin:0 0 20px;padding-left:22px}\n.upl-blog li{margin:0 0 9px}\n.upl-blog figure{margin:0 0 34px}\n.upl-blog figure img{width:100%;height:auto;display:block;border-radius:10px}\n.upl-blog figcaption{font-size:13px;color:#6b7280;margin-top:10px;line-height:1.5}\n.upl-blog .toc{background:none;border:0;border-radius:0;padding:0;margin:0 0 34px}\n.upl-blog .toc .lwptoc{margin:0}\n.upl-blog .toc h4{margin:0 0 10px;font-size:13px;letter-spacing:.1em;text-transform:uppercase;color:#0d5563}\n.upl-blog .toc ol{margin:0;padding-left:18px;font-size:14.5px}\n.upl-blog .toc li{margin-bottom:6px}\n.upl-blog table{width:100%;border-collapse:collapse;font-size:14.5px;margin:0 0 10px}\n.upl-blog th{background:#0d3b47;color:#fff;text-align:left;padding:11px 13px;font-weight:600;font-size:13.5px;border:0}\n.upl-blog td{padding:11px 13px;border:0;border-bottom:1px solid #e8ebed;vertical-align:top}\n.upl-blog tbody tr:nth-child(even){background:#fafbfc}\n.upl-blog .tablecap{font-size:12.5px;color:#6b7280;margin:0 0 30px}\n.upl-blog .myth{background:#fff8ef;border:1px solid #f6ddbd;border-radius:8px;padding:16px 20px;margin:0 0 26px;font-size:15.5px}\n.upl-blog .myth b{color:#a85c10}\n.upl-blog .callout{background:#f2f8f9;border-radius:8px;padding:18px 22px;margin:0 0 26px;font-size:15.5px;border-left:3px solid #14707f}\n.upl-blog .faq h3{border-top:1px solid #eceff1;padding-top:22px;margin-top:0;font-size:18px}\n.upl-blog .faq h3:first-of-type{border-top:0;padding-top:0}\n.upl-blog .cta{background:linear-gradient(135deg,#0b2b33,#0d5563);color:#fff;border-radius:12px;padding:34px;margin:48px 0 30px}\n.upl-blog .cta h2,.upl-blog .cta .cta-h{color:#fff;margin:0 0 10px;font-size:24px;font-weight:700;line-height:1.3}\n.upl-blog .cta p{color:#c9dee3;margin:0 0 20px;font-size:16px}\n.upl-blog .btn{display:inline-block;background:#e07a1f;color:#fff;text-decoration:none;font-weight:700;padding:13px 26px;border-radius:8px;font-size:15.5px}\n.upl-blog .rel{border-top:1px solid #e8ebed;margin-top:40px;padding-top:26px}\n.upl-blog .rel h4{font-size:13px;letter-spacing:.1em;text-transform:uppercase;color:#6b7280;margin:0 0 14px}\n.upl-blog .rel ul{list-style:none;padding:0;margin:0}\n.upl-blog .rel li{padding:11px 0;border-bottom:1px dashed #e8ebed}\n.upl-blog .rel a{text-decoration:none;font-weight:600;font-size:15.5px}\n@media(max-width:640px){.upl-blog h2{font-size:22px}.upl-blog table{font-size:13px}.upl-blog .cta{padding:24px}}\n\/* \u5355\u7bc7\u9875\u9690\u85cf WhatsApp \u95ee\u5019\u5361\uff0c\u53ea\u4fdd\u7559\u5706\u5f62\u6c14\u6ce1\uff0c\u907f\u514d\u906e\u6321\u4fa7\u680f\u8be2\u76d8\u63d0\u4ea4\u6309\u94ae\u3002\n   \u6ce8\u610f\uff1aClick to Chat \u7684\u70b9\u51fb\u903b\u8f91\u662f\u300c\u95ee\u5019\u5361\u5143\u7d20\u5b58\u5728\u5c31\u4e0d\u8df3\u8f6c\u300d\uff0c\u53ea\u9760 CSS \u9690\u85cf\u4f1a\u8ba9\u6c14\u6ce1\u53d8\u6210\u6b7b\u94fe\u63a5\u3002\n   Code Snippets #9\u300cUPL single post: WhatsApp bubble jumps straight to chat\u300d\u8d1f\u8d23\u628a\u8be5\u8282\u70b9\u4ece DOM \u79fb\u9664\uff0c\n   \u4e0b\u9762\u8fd9\u6761 CSS \u53ea\u662f\u79fb\u9664\u524d\u7684\u89c6\u89c9\u515c\u5e95\u3002\u5220 #9 \u524d\u5fc5\u987b\u5148\u5220\u8fd9\u6761\u89c4\u5219\u3002 *\/\nbody.single-post .ht_ctc_chat_greetings_box{display:none !important}\n<\/style>\n<div class=\"upl-blog\">\n<figure>\n<img fetchpriority=\"high\" decoding=\"async\" src=\"https:\/\/uplastech.com\/wp-content\/uploads\/2026\/10\/food-grade-silicone.jpg\" alt=\"EU 10\/2011 overall migration limits by simulant and the scope of food and medical silicone standards\" width=\"1536\" height=\"909\"><figcaption>One limit, six simulants, and a different answer depending on what the part touches.<\/figcaption><\/figure>\n<div class=\"toc\"><\/div>\n<h2 id=\"meaning\">What food grade actually means<\/h2>\n<p>There is no such thing as a food-grade polymer. There are food-contact-compliant formulations, and compliance is a property of the finished article under a specific regulation, for a specific food type, at a specific temperature and time.<\/p>\n<p>For silicone, the base polymer is essentially inert. What determines compliance is everything else: the filler, the curative and its residues, the pigment, the process aids, and the post-cure that drives out volatiles. A compliant base with a non-compliant pigment is a non-compliant part.<\/p>\n<p>This is why the certificate matters more than the datasheet. A supplier who says 'food grade' without naming the regulation, the test conditions and the migration result is describing an intention, not a product.<\/p>\n<h2 id=\"fda\">FDA 21 CFR 177.2600<\/h2>\n<p>The American route regulates the substance. 21 CFR 177.2600 lists the permitted rubber articles intended for repeated use, and specifies which base polymers, fillers and additives may be used, at what levels, and for what food types.<\/p>\n<p>The regulation is built on extraction tests rather than migration into food. A sample is extracted with distilled water for 7 hours at reflux, then with n-hexane for 2 hours at reflux, and the extractables are weighed. The limits are 20 mg per square inch for the aqueous extract and 175 mg per square inch for the hexane extract on the first test, with lower limits on subsequent tests.<\/p>\n<p>Those numbers look generous, and they are. The regulation is a screening tool for repeated-use articles, not a simulation of a specific food contact. It also assumes the article is formulated only from listed substances \u2014 a novel additive makes the whole article non-compliant even if the extraction result is low.<\/p>\n<div class=\"callout\">A 'FDA-approved' silicone is not approved by the FDA. The FDA does not approve materials. A supplier means the formulation uses only 21 CFR 177.2600 listed ingredients and passes the extraction test.<\/div>\n<h2 id=\"eu\">EU 10\/2011: material and migration<\/h2>\n<p>The European route regulates the finished article by what it releases. Regulation 10\/2011 sets an overall migration limit of 10 mg\/dm\u00b2 or 60 mg\/kg of food, and specific migration limits for individual substances.<\/p>\n<p>Silicones are covered as a plastic material under 10\/2011 when they are the food contact layer, and the testing uses food simulants rather than food itself: water, 3 percent acetic acid, 10 percent ethanol, olive oil, 95 percent ethanol and iso-octane, each at a temperature and time that represents the intended use.<\/p>\n<p>The overall limit of 10 mg\/dm\u00b2 is much stricter than the FDA extraction numbers and it is the one that most silicone food articles fail on first test. The usual cause is insufficient post-cure: volatile siloxanes that were never driven out migrate into the simulant.<\/p>\n<table>\n<thead>\n<tr>\n<th>Simulant<\/th>\n<th>Represents<\/th>\n<th>Conditions (typical)<\/th>\n<th>OML<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Distilled water<\/td>\n<td>Aqueous foods<\/td>\n<td>10 days at 40 \u00b0C<\/td>\n<td>10 mg\/dm\u00b2<\/td>\n<\/tr>\n<tr>\n<td>3% acetic acid<\/td>\n<td>Acidic foods<\/td>\n<td>2 h at 70 \u00b0C<\/td>\n<td>60 mg\/kg<\/td>\n<\/tr>\n<tr>\n<td>10% ethanol<\/td>\n<td>Low-alcohol<\/td>\n<td>2 h at 70 \u00b0C<\/td>\n<td>10 mg\/dm\u00b2<\/td>\n<\/tr>\n<tr>\n<td>Olive oil<\/td>\n<td>Fatty foods<\/td>\n<td>2 h at 70 \u00b0C<\/td>\n<td>60 mg\/kg<\/td>\n<\/tr>\n<tr>\n<td>95% ethanol<\/td>\n<td>Fatty, dry<\/td>\n<td>4 h at 60 \u00b0C<\/td>\n<td>60 mg\/kg<\/td>\n<\/tr>\n<tr>\n<td>Iso-octane<\/td>\n<td>Fatty, high temp<\/td>\n<td>2 h at 60 \u00b0C<\/td>\n<td>60 mg\/kg<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p class=\"tablecap\">Table 1 \u2014 EU 10\/2011 simulants and conditions. The limits are expressed per area or per kilogram of food depending on the pack geometry.<\/p>\n<h2 id=\"test\">What the test actually measures<\/h2>\n<p>Overall migration is a gravimetric test: the simulant is evaporated and the residue is weighed. It does not identify what migrated, only how much. A part can pass overall migration and still fail a specific migration limit for a particular siloxane or additive.<\/p>\n<p>For silicone, the substances that matter are the cyclic siloxanes \u2014 D4, D5, D6 \u2014 and any residual catalyst or peroxide fragments. D4 and D5 have specific migration limits in the EU and are the usual reason a silicone article fails after passing the overall test.<\/p>\n<p>Sensory testing is a third requirement that is often forgotten. A silicone part can be fully compliant and still impart a taste or odour to the food, and that is a commercial failure even when it is not a legal one. Post-cure is the control.<\/p>\n<h2 id=\"cure\">Post-cure is the compliance step<\/h2>\n<p>A press-cured silicone part contains volatiles: unreacted oligomers, peroxide fragments if a peroxide cure was used, and filler treatment residues. Post-curing at 200 \u00b0C for 2 to 4 hours drives most of them out.<\/p>\n<p>The effect on migration is large. An un-post-cured part can show an overall migration three to five times higher than the same part after post-cure. This is why a compliant formulation can still produce a failing part, and why the certificate must specify the post-cure condition, not just the compound.<\/p>\n<p>Platinum-cure compounds need post-cure as much as peroxide-cure ones, though for different reasons. Platinum cure leaves fewer acidic fragments but still contains volatile siloxanes from the filler treatment.<\/p>\n<h2 id=\"colour\">Colourants, additives and the things that break compliance<\/h2>\n<table>\n<thead>\n<tr>\n<th>Break<\/th>\n<th>Why it happens<\/th>\n<th>How to avoid<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Non-listed pigment<\/td>\n<td>Cheap colourant without food contact status<\/td>\n<td>Specify a food-contact pigment by name<\/td>\n<\/tr>\n<tr>\n<td>Insufficient post-cure<\/td>\n<td>Cycle time pressure<\/td>\n<td>Write post-cure into the specification<\/td>\n<\/tr>\n<tr>\n<td>Peroxide cure with aromatic fragments<\/td>\n<td>Cheaper curative<\/td>\n<td>Specify platinum cure for food contact<\/td>\n<\/tr>\n<tr>\n<td>Release agent on the mould<\/td>\n<td>External release sprays<\/td>\n<td>Use an internal release or none<\/td>\n<\/tr>\n<tr>\n<td>Regrind from unknown origin<\/td>\n<td>Scrap mixed across jobs<\/td>\n<td>Segregate food-contact regrind<\/td>\n<\/tr>\n<tr>\n<td>Changed filler supplier<\/td>\n<td>Silica treatment differs<\/td>\n<td>Require notification of change<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p class=\"tablecap\">Table 2 \u2014 The six ways a food-contact silicone part loses compliance after it has been qualified.<\/p>\n<p>The most common is a pigment change. A moulder substitutes a colour masterbatch from a different supplier because the original is out of stock, and the new one contains a pigment that is not listed for food contact. The part looks identical and the compliance is gone.<\/p>\n<p>The second most common is a change in post-cure. A part that was qualified with a four-hour post-cure is shipped with a two-hour post-cure because the oven was needed for another job. The dimensions are the same and the migration is double.<\/p>\n<h2 id=\"documents\">What to ask for<\/h2>\n<p>Ask for four documents and check that they match the part you are buying. A Declaration of Compliance naming the regulation and the food contact conditions. A migration test report from an accredited laboratory, on the finished article, not on a test sheet. A formulation statement listing the pigments and additives. And a process specification that states the post-cure temperature and time.<\/p>\n<p>If any of the four is missing, the supplier is offering a material rather than a part. That distinction is the whole point of food contact regulation.<\/p>\n<div class=\"faq\">\n<h3>What makes silicone food grade?<\/h3>\n<p>A compliant formulation \u2014 base, filler, curative and pigment all listed for food contact \u2014 plus a post-cure that removes volatiles, plus migration testing on the finished article. The base polymer alone does not make it food grade.<\/p>\n<h3>Is FDA approval the same as EU compliance?<\/h3>\n<p>No. FDA 21 CFR 177.2600 regulates permitted substances and extraction limits; EU 10\/2011 regulates migration into food simulants. A part compliant in one market is not automatically compliant in the other.<\/p>\n<h3>What is the overall migration limit for silicone in the EU?<\/h3>\n<p>10 mg\/dm\u00b2 of surface area or 60 mg\/kg of food, depending on the pack geometry. It is stricter than the FDA extraction limits and is the usual reason a silicone article fails first time.<\/p>\n<h3>Why does food-grade silicone need post-curing?<\/h3>\n<p>To drive out volatile siloxanes and cure by-products. An un-post-cured part can show three to five times the migration of the same part after post-cure at 200 \u00b0C for four hours.<\/p>\n<h3>Can coloured silicone be food grade?<\/h3>\n<p>Yes, if the pigment itself is listed for food contact. Many pigments are not, and substituting a colourant without checking is the most common cause of compliance loss after qualification.<\/p>\n<h3>What is the difference between food grade and medical grade silicone?<\/h3>\n<p>Food grade is about migration into food; medical grade is about biocompatibility and extractables in a clinical context. Some materials meet both, but the tests and the documentation are different.<\/p>\n<\/div>\n<div class=\"cta\">\n<p class=\"cta-h\">Sourcing food-contact silicone parts?<\/p>\n<p>Tell us the food type, the contact temperature and the market. We will tell you which regulation applies and what the post-cure has to be.<\/p>\n<p><a class=\"btn\" href=\"https:\/\/uplastech.com\/ja\/custom-injection-molding\/\">Talk to a silicone engineer<\/a>\n<\/div>\n<div class=\"rel\">\n<h4>Continue reading<\/h4>\n<ul>\n<li><a href=\"https:\/\/uplastech.com\/ja\/medical-grade-silicone\/\">Medical-Grade Silicone: USP Class VI and ISO 10993<\/a><\/li>\n<li><a href=\"https:\/\/uplastech.com\/ja\/silicone-rubber-types-guide\/\">Silicone Rubber Types: HCR, LSR and RTV<\/a><\/li>\n<li><a href=\"https:\/\/uplastech.com\/ja\/silicone-compound-formulation\/\">Silicone Compound Formulation: Base, Filler and Cure<\/a><\/li>\n<li><a href=\"https:\/\/uplastech.com\/ja\/food-contact-thermoforming-compliance\/\">Food Contact Compliance for Thermoformed Packaging<\/a><\/li>\n<li><a href=\"https:\/\/uplastech.com\/ja\/silicone-vs-tpe-vs-natural-rubber\/\">Silicone Versus TPE and Natural Rubber<\/a><\/li>\n<\/ul>\n<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Food-grade silicone is not a material property, it is a set of documents. FDA, EU 10\/2011 and BfR XV ask different questions, and a part that passes one is not automatically compliant in the other.<\/p>","protected":false},"author":1,"featured_media":7809,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_seopress_titles_title":"Food-Grade Silicone: FDA, EU 10\/2011 and Migration Testing","_seopress_titles_desc":"Food-grade silicone compliance: FDA 21 CFR 177.2600, EU 10\/2011 overall migration, the six simulants, post-cure, colourant restrictions and where compliance act","_seopress_robots_index":"","_seopress_robots_follow":"","_seopress_robots_imageindex":"","_seopress_robots_snippet":"","_seopress_robots_primary_cat":"39","_seopress_robots_breadcrumbs":"","_seopress_robots_freeze_modified_date":"","_seopress_robots_custom_modified_date":"","_seopress_robots_canonical":"","_seopress_social_fb_title":"","_seopress_social_fb_desc":"","_seopress_social_fb_img":"","_seopress_social_fb_img_attachment_id":0,"_seopress_social_fb_img_width":0,"_seopress_social_fb_img_height":0,"_seopress_social_twitter_title":"","_seopress_social_twitter_desc":"","_seopress_social_twitter_img":"","_seopress_social_twitter_img_attachment_id":0,"_seopress_social_twitter_img_width":0,"_seopress_social_twitter_img_height":0,"_seopress_redirections_value":"","_seopress_redirections_enabled":"","_seopress_redirections_enabled_regex":"","_seopress_redirections_logged_status":"","_seopress_redirections_param":"","_seopress_redirections_type":0,"_seopress_analysis_target_kw":"","footnotes":""},"categories":[39],"tags":[],"class_list":["post-7810","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-silicone-rubber-products"],"meta_box":{"post-to-quiz_to":[]},"_links":{"self":[{"href":"https:\/\/uplastech.com\/ja\/wp-json\/wp\/v2\/posts\/7810","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/uplastech.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/uplastech.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/uplastech.com\/ja\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/uplastech.com\/ja\/wp-json\/wp\/v2\/comments?post=7810"}],"version-history":[{"count":1,"href":"https:\/\/uplastech.com\/ja\/wp-json\/wp\/v2\/posts\/7810\/revisions"}],"predecessor-version":[{"id":7869,"href":"https:\/\/uplastech.com\/ja\/wp-json\/wp\/v2\/posts\/7810\/revisions\/7869"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/uplastech.com\/ja\/wp-json\/wp\/v2\/media\/7809"}],"wp:attachment":[{"href":"https:\/\/uplastech.com\/ja\/wp-json\/wp\/v2\/media?parent=7810"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/uplastech.com\/ja\/wp-json\/wp\/v2\/categories?post=7810"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/uplastech.com\/ja\/wp-json\/wp\/v2\/tags?post=7810"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}