FDA 21 CFR: American compliance for components in contact with food<\/title>\n\n <link rel=\"preconnect\" href=\"https:\/\/fonts.googleapis.com\">\n <link rel=\"preconnect\" href=\"https:\/\/fonts.gstatic.com\" crossorigin=\"\">\n <link href=\"https:\/\/fonts.googleapis.com\/css2?family=Inter:wght@400;500;600;700&display=swap\" rel=\"stylesheet\">\n\n <style>\n *, *::before, *::after { box-sizing: border-box; margin: 0; padding: 0; }\n\n :root {\n --green: #1a6b3c;\n --green-dark: #0f4a28;\n --green-mid: #2d8a55;\n --green-light: #e8f4ed;\n --green-xlight: #f2faf5;\n --amber: #b45309;\n --amber-light: #fef3c7;\n\n --bg: #ffffff;\n --bg-soft: #f8f9fa;\n --bg-muted: #f1f3f5;\n --border: #e5e7eb;\n --border-mid: #d1d5db;\n\n --text-primary: #111827;\n --text-secondary: #4b5563;\n --text-muted: #9ca3af;\n\n --radius-sm: 6px;\n --radius-md: 8px;\n --radius-lg: 12px;\n --shadow-sm: 0 1px 3px rgba(0,0,0,.06), 0 1px 2px rgba(0,0,0,.04);\n --shadow-md: 0 4px 12px rgba(0,0,0,.08), 0 2px 4px rgba(0,0,0,.04);\n }\n\n body { min-height: 100vh; 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The European certification you already have (EU Reg. 10\/2011) isn't enough: the American system works differently, and understanding the differences lets you respond precisely instead of deferring the matter to the material supplier.\",\n \"inLanguage\": \"en\"\n }\n ]\n}\n<\/script>\n\n\n\n <h1 class=\"article__title\">FDA 21 CFR: American compliance for components in contact with food<\/h1>\n<p class=\"article__subtitle\">You export technopolymer components to the USA and your customer asks for FDA compliance. The European certification you already have (<strong>EU Reg. 10\/2011<\/strong>) isn’t enough: the American system works differently, and understanding the differences lets you respond precisely instead of deferring the matter to the material supplier.<\/p>\n<h2 class=\"article__h2\" id=\"structure-of-21-cfr\">\n <span class=\"article__h2-icon\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"16\" height=\"16\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M4 15s1-1 4-1 5 2 8 2 4-1 4-1V3s-1 1-4 1-5-2-8-2-4 1-4 1z\"><\/path><line x1=\"4\" y1=\"22\" x2=\"4\" y2=\"15\"><\/line><\/svg><\/span>\n Structure of 21 CFR\n<\/h2>\n<p class=\"article__p\">The <strong>Code of Federal Regulations Title 21 (21 CFR)<\/strong> is the collection of American federal regulations on food, drugs and medical devices, issued by the <strong>FDA<\/strong> (Food and Drug Administration). For plastic materials in contact with food, the main sections are <strong>Part 177<\/strong> (Indirect Food Additives: Polymers) and <strong>Part 178<\/strong> (Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers).<\/p>\n<p class=\"article__p\">The logic is different from the European one. The 21 CFR lists, for each type of polymer, the permitted conditions of use: type of food, maximum temperature, conditions of use. You don’t find a single centralized positive list as in the EU, but a series of sheets per material.<\/p>\n<div class=\"article__table-wrap\">\n<table class=\"article__table\">\n<thead><tr><th>Material<\/th><th>21 CFR section<\/th><th>Main conditions<\/th><\/tr><\/thead>\n<tbody><tr><td>Polyacetal (POM)<\/td><td>177.2470<\/td><td>Use with all types of food<\/td><\/tr>\n<tr><td>Polyamide (PA)<\/td><td>177.1500<\/td><td>Limitations on temperature and type of food<\/td><\/tr>\n<tr><td>PEEK<\/td><td>177.2415<\/td><td>High temperature, direct contact<\/td><\/tr>\n<tr><td>Polypropylene<\/td><td>177.1520<\/td><td>General use, verify additives<\/td><\/tr>\n<tr><td>Polyethylene (HD\/LD)<\/td><td>177.1520 \/ 177.1510<\/td><td>General use<\/td><\/tr>\n<tr><td>PTFE<\/td><td>177.1550<\/td><td>Wide use, including high temperature<\/td><\/tr><\/tbody>\n<\/table>\n<\/div>\n<h2 class=\"article__h2\" id=\"differences-with-the-european-regulation\">\n <span class=\"article__h2-icon\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"16\" height=\"16\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M12 3v18\"><\/path><path d=\"m3 7 5 5-5 5\"><\/path><path d=\"m21 7-5 5 5 5\"><\/path><path d=\"M3 7h18\"><\/path><path d=\"M6 12H3\"><\/path><path d=\"M21 12h-3\"><\/path><\/svg><\/span>\n Differences with the European regulation\n<\/h2>\n<p class=\"article__p\">When you go from EU to USA, you aren’t only changing the regulatory label: the system logic changes.<\/p>\n<p class=\"article__p\">The 21 CFR doesn’t impose systematic migration tests. It specifies instead the permitted composition and the conditions of use. EU Reg. 10\/2011, on the contrary, requires migration tests and a formal declaration of conformity. The 21 CFR is more prescriptive on the material composition; the EU regulation is more up to date on previously unregulated substances, thanks to the recent amendments.<\/p>\n<div class=\"warnbox\">\n <div class=\"warnbox__title\">\n <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"14\" height=\"14\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M10.29 3.86L1.82 18a2 2 0 0 0 1.71 3h16.94a2 2 0 0 0 1.71-3L13.71 3.86a2 2 0 0 0-3.42 0z\"><\/path><line x1=\"12\" y1=\"9\" x2=\"12\" y2=\"13\"><\/line><line x1=\"12\" y1=\"17\" x2=\"12.01\" y2=\"17\"><\/line><\/svg>\n Warning\n <\/div>\n <p class=\"warnbox__text\">EU compliance <strong>doesn’t automatically hold<\/strong> for the American market. Even if your component is compliant with EU Reg. 10\/2011, you must verify that the specific material is listed in the applicable 21 CFR sections, under the foreseen conditions of use.<\/p>\n<\/div>\n<h2 class=\"article__h2\" id=\"self-affirmation-the-american-mechanism\">\n <span class=\"article__h2-icon\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"16\" height=\"16\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M22 11.08V12a10 10 0 1 1-5.93-9.14\"><\/path><polyline points=\"22 4 12 14.01 9 11.01\"><\/polyline><\/svg><\/span>\n Self-affirmation: the American mechanism\n<\/h2>\n<p class=\"article__p\">Not everything you use is explicitly listed in the 21 CFR. For substances not covered, the FDA recognizes two alternative paths: <strong>GRAS<\/strong> (Generally Recognized As Safe, substances recognized as safe on the basis of scientific consensus) and <strong>FCN<\/strong> (Food Contact Notification, a formal notification to the FDA).<\/p>\n<p class=\"article__p\">Many technopolymer manufacturers for food use have chosen the <strong>self-affirmation<\/strong> route: they document internally the complete toxicological assessment of the material under the foreseen conditions of use and make this documentation available on request. If your supplier has taken this road, you can market the component as food-contact compliant even when the specific formulation doesn’t appear in the 21 CFR.<\/p>\n<div class=\"infobox infobox--grey\">\n <div class=\"infobox__title\">\n <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"14\" height=\"14\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M14.7 6.3a1 1 0 0 0 0 1.4l1.6 1.6a1 1 0 0 0 1.4 0l3.77-3.77a6 6 0 0 1-7.94 7.94l-6.91 6.91a2.12 2.12 0 0 1-3-3l6.91-6.91a6 6 0 0 1 7.94-7.94l-3.76 3.76z\"><\/path><\/svg>\n Technical note\n <\/div>\n <p class=\"infobox__text\">Self-affirmation isn’t a shortcut. It’s a formal mechanism recognized by the FDA, but the soundness of the supporting technical document is decisive in case of inspection or dispute.<\/p>\n<\/div>\n<h2 class=\"article__h2\" id=\"what-to-ask-the-material-supplier\">\n <span class=\"article__h2-icon\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"16\" height=\"16\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><circle cx=\"12\" cy=\"12\" r=\"10\"><\/circle><\/svg><\/span>\n What to ask the material supplier\n<\/h2>\n<p class=\"article__p\">For a component intended for the American market, request from the supplier:<\/p>\n<ol class=\"article__list\">\n <li>The <strong>21 CFR section<\/strong> applicable to the specific material in the marketed formulation<\/li>\n <li>Any <strong>usage limitations<\/strong>: temperature, type of food, conditions of use<\/li>\n <li>The <strong>self-affirmation document<\/strong> or the GRAS notification, if available<\/li>\n<\/ol>\n<p class=\"article__p\">Always ask that the compliance letter refer to the exact commercial formulation, not to the generic base polymer.<\/p>\n<h2 class=\"article__h2\" id=\"colorants-and-additives-the-critical-point\">\n <span class=\"article__h2-icon\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"16\" height=\"16\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><circle cx=\"12\" cy=\"12\" r=\"10\"><\/circle><\/svg><\/span>\n Colorants and additives: the critical point\n<\/h2>\n<p class=\"article__p\">The base polymer (POM, PA, PEEK) in the natural formulation, that is, the raw white or ivory, is generally compliant with the applicable 21 CFR sections. The problems arise when colorants, functional additives (fillers, internal lubricants, UV stabilizers) and composite materials such as glass-fiber reinforced PA or POM with graphite come into play.<\/p>\n<div class=\"warnbox\">\n <div class=\"warnbox__title\">\n <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"14\" height=\"14\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M10.29 3.86L1.82 18a2 2 0 0 0 1.71 3h16.94a2 2 0 0 0 1.71-3L13.71 3.86a2 2 0 0 0-3.42 0z\"><\/path><line x1=\"12\" y1=\"9\" x2=\"12\" y2=\"13\"><\/line><line x1=\"12\" y1=\"17\" x2=\"12.01\" y2=\"17\"><\/line><\/svg>\n Warning\n <\/div>\n <p class=\"warnbox__text\">Always verify compliance on the <strong>complete commercial formulation<\/strong>, not just on the base polymer. A material described as “food grade” by the manufacturer must have specific documentary support referring to the commercial formulation in use, not to the family of materials.<\/p>\n<\/div>\n<div class=\"infobox\">\n <div class=\"infobox__title\">\n <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"14\" height=\"14\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M4 4h16c1.1 0 2 .9 2 2v12c0 1.1-.9 2-2 2H4c-1.1 0-2-.9-2-2V6c0-1.1.9-2 2-2z\"><\/path><polyline points=\"22,6 12,13 2,6\"><\/polyline><\/svg>\n Ask us\n <\/div>\n <p class=\"infobox__text\">If you’re selecting a material for a component intended for the American market and have doubts about which 21 CFR section applies to your specific configuration, <a href=\"https:\/\/shop.stagnoligears.com\/en\/contacts\/\" target=\"_blank\" rel=\"noopener\" class=\"cta-link\">contact<\/a> the technical office: we assess the available 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{"id":25627,"date":"2026-06-30T14:40:50","date_gmt":"2026-06-30T12:40:50","guid":{"rendered":"https:\/\/shop.stagnoligears.com\/?post_type=centro-tecnico&p=25627"},"modified":"2026-07-10T13:51:03","modified_gmt":"2026-07-10T11:51:03","slug":"fda-21-cfr-american-compliance-for-components-in-contact-with-food","status":"publish","type":"centro-tecnico","link":"https:\/\/shop.stagnoligears.com\/en\/technical-hub\/fda-21-cfr-american-compliance-for-components-in-contact-with-food\/","title":{"rendered":"FDA 21 CFR: American compliance for components in contact with food"},"content":{"rendered":"\n\n \n \n \n FDA 21 CFR: American compliance for components in contact with food<\/title>\n\n <link rel=\"preconnect\" href=\"https:\/\/fonts.googleapis.com\">\n <link rel=\"preconnect\" href=\"https:\/\/fonts.gstatic.com\" crossorigin=\"\">\n <link href=\"https:\/\/fonts.googleapis.com\/css2?family=Inter:wght@400;500;600;700&display=swap\" rel=\"stylesheet\">\n\n <style>\n *, *::before, *::after { box-sizing: border-box; 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}\n\n .badge {\n display: inline-block;\n font-size: 12px;\n font-weight: 600;\n padding: 2px 8px;\n border-radius: 20px;\n background: var(--green-light);\n color: var(--green-dark);\n }\n\n \/* ============================================================\n RESPONSIVE\n ============================================================ *\/\n @media (max-width: 900px) {\n .article-body { flex-direction: column; padding: 20px 20px 48px; }\n }\n \n \/* Glossary tooltips *\/\n .glossary-term {\n border-bottom: 1px dotted var(--green);\n color: var(--green);\n font-style: italic;\n cursor: help;\n }\n .glossary-tooltip {\n position: fixed;\n z-index: 9999;\n background: #fff;\n border: 1px solid var(--border-mid);\n border-radius: var(--radius-md);\n box-shadow: var(--shadow-md);\n padding: 10px 14px;\n max-width: 300px;\n font-family: 'Inter', sans-serif;\n font-size: 13px;\n }\n .glossary-tooltip__title {\n font-weight: 600;\n color: var(--text-primary);\n margin-bottom: 4px;\n }\n .glossary-tooltip__def {\n font-size: 12.5px;\n color: var(--text-secondary);\n line-height: 1.6;\n }\n .glossary-tooltip__tag {\n display: inline-block;\n margin-top: 6px;\n font-size: 9px;\n font-weight: 600;\n padding: 2px 7px;\n border-radius: 20px;\n background: var(--green-light);\n color: var(--green-dark);\n text-transform: uppercase;\n letter-spacing: 0.04em;\n }\n\n <\/style>\n<\/head>\n<body>\n\n\n <div class=\"article-page\">\n <div class=\"article-body\">\n <div class=\"article-body__main\"><script type=\"application\/ld+json\">\n{\n \"@context\": \"https:\/\/schema.org\",\n \"@graph\": [\n {\n \"@type\": \"TechArticle\",\n \"@id\": \"#article\",\n \"headline\": \"FDA 21 CFR: American compliance for components in contact with food\",\n \"description\": \"You export technopolymer components to the USA and your customer asks for FDA compliance. The European certification you already have (EU Reg. 10\/2011) isn't enough: the American system works differently, and understanding the differences lets you respond precisely instead of deferring the matter to the material supplier.\",\n \"inLanguage\": \"en\"\n }\n ]\n}\n<\/script>\n\n\n\n <h1 class=\"article__title\">FDA 21 CFR: American compliance for components in contact with food<\/h1>\n<p class=\"article__subtitle\">You export technopolymer components to the USA and your customer asks for FDA compliance. The European certification you already have (<strong>EU Reg. 10\/2011<\/strong>) isn’t enough: the American system works differently, and understanding the differences lets you respond precisely instead of deferring the matter to the material supplier.<\/p>\n<h2 class=\"article__h2\" id=\"structure-of-21-cfr\">\n <span class=\"article__h2-icon\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"16\" height=\"16\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M4 15s1-1 4-1 5 2 8 2 4-1 4-1V3s-1 1-4 1-5-2-8-2-4 1-4 1z\"><\/path><line x1=\"4\" y1=\"22\" x2=\"4\" y2=\"15\"><\/line><\/svg><\/span>\n Structure of 21 CFR\n<\/h2>\n<p class=\"article__p\">The <strong>Code of Federal Regulations Title 21 (21 CFR)<\/strong> is the collection of American federal regulations on food, drugs and medical devices, issued by the <strong>FDA<\/strong> (Food and Drug Administration). For plastic materials in contact with food, the main sections are <strong>Part 177<\/strong> (Indirect Food Additives: Polymers) and <strong>Part 178<\/strong> (Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers).<\/p>\n<p class=\"article__p\">The logic is different from the European one. The 21 CFR lists, for each type of polymer, the permitted conditions of use: type of food, maximum temperature, conditions of use. You don’t find a single centralized positive list as in the EU, but a series of sheets per material.<\/p>\n<div class=\"article__table-wrap\">\n<table class=\"article__table\">\n<thead><tr><th>Material<\/th><th>21 CFR section<\/th><th>Main conditions<\/th><\/tr><\/thead>\n<tbody><tr><td>Polyacetal (POM)<\/td><td>177.2470<\/td><td>Use with all types of food<\/td><\/tr>\n<tr><td>Polyamide (PA)<\/td><td>177.1500<\/td><td>Limitations on temperature and type of food<\/td><\/tr>\n<tr><td>PEEK<\/td><td>177.2415<\/td><td>High temperature, direct contact<\/td><\/tr>\n<tr><td>Polypropylene<\/td><td>177.1520<\/td><td>General use, verify additives<\/td><\/tr>\n<tr><td>Polyethylene (HD\/LD)<\/td><td>177.1520 \/ 177.1510<\/td><td>General use<\/td><\/tr>\n<tr><td>PTFE<\/td><td>177.1550<\/td><td>Wide use, including high temperature<\/td><\/tr><\/tbody>\n<\/table>\n<\/div>\n<h2 class=\"article__h2\" id=\"differences-with-the-european-regulation\">\n <span class=\"article__h2-icon\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"16\" height=\"16\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M12 3v18\"><\/path><path d=\"m3 7 5 5-5 5\"><\/path><path d=\"m21 7-5 5 5 5\"><\/path><path d=\"M3 7h18\"><\/path><path d=\"M6 12H3\"><\/path><path d=\"M21 12h-3\"><\/path><\/svg><\/span>\n Differences with the European regulation\n<\/h2>\n<p class=\"article__p\">When you go from EU to USA, you aren’t only changing the regulatory label: the system logic changes.<\/p>\n<p class=\"article__p\">The 21 CFR doesn’t impose systematic migration tests. It specifies instead the permitted composition and the conditions of use. EU Reg. 10\/2011, on the contrary, requires migration tests and a formal declaration of conformity. The 21 CFR is more prescriptive on the material composition; the EU regulation is more up to date on previously unregulated substances, thanks to the recent amendments.<\/p>\n<div class=\"warnbox\">\n <div class=\"warnbox__title\">\n <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"14\" height=\"14\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M10.29 3.86L1.82 18a2 2 0 0 0 1.71 3h16.94a2 2 0 0 0 1.71-3L13.71 3.86a2 2 0 0 0-3.42 0z\"><\/path><line x1=\"12\" y1=\"9\" x2=\"12\" y2=\"13\"><\/line><line x1=\"12\" y1=\"17\" x2=\"12.01\" y2=\"17\"><\/line><\/svg>\n Warning\n <\/div>\n <p class=\"warnbox__text\">EU compliance <strong>doesn’t automatically hold<\/strong> for the American market. Even if your component is compliant with EU Reg. 10\/2011, you must verify that the specific material is listed in the applicable 21 CFR sections, under the foreseen conditions of use.<\/p>\n<\/div>\n<h2 class=\"article__h2\" id=\"self-affirmation-the-american-mechanism\">\n <span class=\"article__h2-icon\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"16\" height=\"16\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M22 11.08V12a10 10 0 1 1-5.93-9.14\"><\/path><polyline points=\"22 4 12 14.01 9 11.01\"><\/polyline><\/svg><\/span>\n Self-affirmation: the American mechanism\n<\/h2>\n<p class=\"article__p\">Not everything you use is explicitly listed in the 21 CFR. For substances not covered, the FDA recognizes two alternative paths: <strong>GRAS<\/strong> (Generally Recognized As Safe, substances recognized as safe on the basis of scientific consensus) and <strong>FCN<\/strong> (Food Contact Notification, a formal notification to the FDA).<\/p>\n<p class=\"article__p\">Many technopolymer manufacturers for food use have chosen the <strong>self-affirmation<\/strong> route: they document internally the complete toxicological assessment of the material under the foreseen conditions of use and make this documentation available on request. If your supplier has taken this road, you can market the component as food-contact compliant even when the specific formulation doesn’t appear in the 21 CFR.<\/p>\n<div class=\"infobox infobox--grey\">\n <div class=\"infobox__title\">\n <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"14\" height=\"14\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M14.7 6.3a1 1 0 0 0 0 1.4l1.6 1.6a1 1 0 0 0 1.4 0l3.77-3.77a6 6 0 0 1-7.94 7.94l-6.91 6.91a2.12 2.12 0 0 1-3-3l6.91-6.91a6 6 0 0 1 7.94-7.94l-3.76 3.76z\"><\/path><\/svg>\n Technical note\n <\/div>\n <p class=\"infobox__text\">Self-affirmation isn’t a shortcut. It’s a formal mechanism recognized by the FDA, but the soundness of the supporting technical document is decisive in case of inspection or dispute.<\/p>\n<\/div>\n<h2 class=\"article__h2\" id=\"what-to-ask-the-material-supplier\">\n <span class=\"article__h2-icon\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"16\" height=\"16\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><circle cx=\"12\" cy=\"12\" r=\"10\"><\/circle><\/svg><\/span>\n What to ask the material supplier\n<\/h2>\n<p class=\"article__p\">For a component intended for the American market, request from the supplier:<\/p>\n<ol class=\"article__list\">\n <li>The <strong>21 CFR section<\/strong> applicable to the specific material in the marketed formulation<\/li>\n <li>Any <strong>usage limitations<\/strong>: temperature, type of food, conditions of use<\/li>\n <li>The <strong>self-affirmation document<\/strong> or the GRAS notification, if available<\/li>\n<\/ol>\n<p class=\"article__p\">Always ask that the compliance letter refer to the exact commercial formulation, not to the generic base polymer.<\/p>\n<h2 class=\"article__h2\" id=\"colorants-and-additives-the-critical-point\">\n <span class=\"article__h2-icon\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"16\" height=\"16\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><circle cx=\"12\" cy=\"12\" r=\"10\"><\/circle><\/svg><\/span>\n Colorants and additives: the critical point\n<\/h2>\n<p class=\"article__p\">The base polymer (POM, PA, PEEK) in the natural formulation, that is, the raw white or ivory, is generally compliant with the applicable 21 CFR sections. The problems arise when colorants, functional additives (fillers, internal lubricants, UV stabilizers) and composite materials such as glass-fiber reinforced PA or POM with graphite come into play.<\/p>\n<div class=\"warnbox\">\n <div class=\"warnbox__title\">\n <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"14\" height=\"14\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M10.29 3.86L1.82 18a2 2 0 0 0 1.71 3h16.94a2 2 0 0 0 1.71-3L13.71 3.86a2 2 0 0 0-3.42 0z\"><\/path><line x1=\"12\" y1=\"9\" x2=\"12\" y2=\"13\"><\/line><line x1=\"12\" y1=\"17\" x2=\"12.01\" y2=\"17\"><\/line><\/svg>\n Warning\n <\/div>\n <p class=\"warnbox__text\">Always verify compliance on the <strong>complete commercial formulation<\/strong>, not just on the base polymer. A material described as “food grade” by the manufacturer must have specific documentary support referring to the commercial formulation in use, not to the family of materials.<\/p>\n<\/div>\n<div class=\"infobox\">\n <div class=\"infobox__title\">\n <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"14\" height=\"14\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M4 4h16c1.1 0 2 .9 2 2v12c0 1.1-.9 2-2 2H4c-1.1 0-2-.9-2-2V6c0-1.1.9-2 2-2z\"><\/path><polyline points=\"22,6 12,13 2,6\"><\/polyline><\/svg>\n Ask us\n <\/div>\n <p class=\"infobox__text\">If you’re selecting a material for a component intended for the American market and have doubts about which 21 CFR section applies to your specific configuration, <a href=\"https:\/\/shop.stagnoligears.com\/en\/contacts\/\" target=\"_blank\" rel=\"noopener\" class=\"cta-link\">contact<\/a> the technical office: we assess the available documentation together.<\/p>\n<\/div>\n\n <\/div>\n <\/div>\n <\/div>\n\n\n<script>\n (function () {\n var hideTimers = {};\n function positionTooltip(trigger, tooltip) {\n var margin = 8;\n tooltip.style.visibility = 'hidden';\n tooltip.style.top = '-9999px';\n tooltip.style.left = '-9999px';\n tooltip.removeAttribute('hidden');\n var ttRect = tooltip.getBoundingClientRect();\n var trRect = trigger.getBoundingClientRect();\n var vw = window.innerWidth, vh = window.innerHeight;\n var top = trRect.bottom + margin;\n var left = trRect.left;\n if (top + ttRect.height + margin > vh) {\n var above = trRect.top - ttRect.height - margin;\n top = above >= margin ? above : Math.max(margin, vh - ttRect.height - margin);\n }\n if (left + ttRect.width + margin > vw) left = vw - ttRect.width - margin;\n if (left < margin) left = margin;\n tooltip.style.top = top + 'px';\n tooltip.style.left = left + 'px';\n tooltip.style.visibility = '';\n }\n function showTooltip(ttId, trigger) {\n if 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});\n })();\n<\/script>\n\n<\/body><\/html>\n","protected":false},"excerpt":{"rendered":"<p>US federal standards for polymer food suitability, featuring positive lists and extraction tests for exporters to the USA.<\/p>\n","protected":false},"parent":0,"template":"","meta":{"_acf_changed":false},"campo-applicazione":[5460],"categoria-ct":[5450],"class_list":["post-25627","centro-tecnico","type-centro-tecnico","status-publish","hentry","campo-applicazione-standards-regulations","categoria-ct-food-grade-compliance-and-regulations"],"acf":[],"yoast_head":"\n<title>FDA 21 CFR Compliance for Food-Contact Components | Stagnoli Gears Shop<\/title>\n<meta name=\"description\" content=\"Understand FDA 21 CFR compliance for technopolymer components in contact with food, including materials, conditions of use and US requirements.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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