{"id":17771,"date":"2026-05-01T10:11:28","date_gmt":"2026-05-01T08:11:28","guid":{"rendered":"https:\/\/lindemannsilikon.de\/2026\/05\/01\/ist-silikon-lebensmittelecht-bfr-xv-fda-21-cfr-177-2600-2\/"},"modified":"2026-05-01T10:11:28","modified_gmt":"2026-05-01T08:11:28","slug":"ist-silikon-lebensmittelecht-bfr-xv-fda-21-cfr-177-2600-2","status":"publish","type":"post","link":"https:\/\/lindemannsilikon.de\/en\/2026\/05\/01\/ist-silikon-lebensmittelecht-bfr-xv-fda-21-cfr-177-2600-2\/","title":{"rendered":"Is silicone food-safe? LFGB, BfR XV, FDA 21 CFR 177.2600 \u2013 the practical guide"},"content":{"rendered":"\n<p><strong>Short answer:<\/strong> According to the current state of science and technology, silicone is considered <strong>food-safe<\/strong> if it meets the requirements of <a href=\"https:\/\/www.bfr.bund.de\/de\/bfr_empfehlungen_zu_materialien_fuer_den_lebensmittelkontakt-447.html\" rel=\"noopener\" target=\"_blank\">BfR Recommendation XV &#8220;Silicones&#8221;<\/a> in conjunction with \u00a7\u00a7 30\/31 LFGB and Article 3 of Regulation (EC) No. 1935\/2004. In the USA, the reference is <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-B\/part-177\/subpart-C\/section-177.2600\" rel=\"noopener\" target=\"_blank\">21 CFR 177.2600<\/a> of the FDA. Practical values: approved cross-linking systems (typically platinum-catalyzed), controlled migration in standardized food simulants, continuous operating temperature typically \u201350 \u00b0C to +200 \u00b0C.<\/p>\n\n\n\n<p>Anyone using silicone hoses\/tubes, silicone gaskets, or silicone molded parts in the <strong>food, beverage, or pharmaceutical industry<\/strong> often hears the term &#8220;food-safe&#8221; without context. This article explains what the term is based on in Germany and the EU, which standards and migration limits apply, what manufacturers must document \u2013 and where processors should pay particular attention.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"rechtsrahmen\">What exactly does &#8220;food-safe&#8221; mean legally?<\/h2>\n\n\n\n<p>The term &#8220;food-safe&#8221; is not a free advertising term, but refers in the EU to a clearly regulated framework for materials and articles intended to come into contact with food (so-called <em>Food Contact Materials<\/em>, FCM). Three levels interlock:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>EU Regulation 1935\/2004<\/strong> \u2013 Framework Regulation. Article 3 requires that materials, under normal or foreseeable conditions of use, <em>do not transfer constituents to food in quantities that could endanger human health, change the composition of the food in an unacceptable way, or bring about a deterioration in the organoleptic characteristics thereof<\/em>.<\/li>\n<li><strong>EU Regulation 2023\/2006<\/strong> \u2013 Good Manufacturing Practice (GMP) for FCM.<\/li>\n<li><strong>LFGB (\u00a7\u00a7 30, 31)<\/strong> in Germany \u2013 national concretization, with reference to recommendations from the Federal Institute for Risk Assessment (BfR).<\/li>\n<\/ul>\n\n\n\n<p>Since silicones are not listed in the harmonized EU list of approved plastics (Regulation 10\/2011), <strong>BfR Recommendation XV &#8220;Silicones&#8221;<\/strong> is of particular importance in practice. It defines permissible starting materials, cross-linking systems, and testing requirements and is considered the state of the art.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"bfr-xv\">BfR Recommendation XV: what it regulates<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Permissible polymer base (poly(organo)siloxane types with methyl, phenyl, vinyl, or trifluoropropyl groups).<\/li>\n<li>Permissible cross-linkers and catalysts \u2013 in food technology, <em>platinum-catalyzed (addition-curing) systems<\/em> dominate because they do not release peroxidic cleavage products.<\/li>\n<li>Requirements for volatile organic components (residual monomers\/oligomers): Manufacturers of food-contact parts typically subject their compounds to <strong>post-curing<\/strong> to bring these below the required value.<\/li>\n<li>Migration testing with the usual <strong>food simulants<\/strong> (e.g., 3% acetic acid, 10%\/50% ethanol, vegetable oil\/olive oil) at a defined time\/temperature combination.<\/li>\n<\/ul>\n\n\n\n<p>The result is a <strong>Declaration of Compliance (DoC)<\/strong>, which every reputable supplier provides for food-safe silicone components. Without a DoC, &#8220;food-safe&#8221; is practically not verifiable in audit contexts.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"fda\">And in the USA? FDA 21 CFR 177.2600<\/h2>\n\n\n\n<p>For applications exported to the USA, the relevant regulation is <strong>21 CFR 177.2600 \u2013 &#8220;Rubber articles intended for repeated use&#8221;<\/strong>. The standard defines permissible silicone elastomers (Si-, Vsi-, Psi-, Fsi-, PVsi-types) suitable for repeated food contact and prescribes two tests:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>Extraction test in distilled water at reflux (7 hours initially, then 2 hours) \u2013 maximum extractable components are limited.<\/li>\n<li>Extraction test in n-hexane under analogous conditions.<\/li>\n<\/ol>\n\n\n\n<p>The FDA lists permissible components in two groups (generally permissible and substances permissible only under restrictions). Suppliers usually declare conformity as <em>&#8220;FDA 21 CFR 177.2600 compliant&#8221;<\/em>, supplemented by the tested range (e.g., water\/oil-based foods).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"standards-uebersicht\">Which standards apply in summary?<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table>\n<thead><tr><th>Region<\/th><th>Framework<\/th><th>Specific requirement for silicone<\/th><\/tr><\/thead>\n<tbody>\n<tr><td>EU<\/td><td>VO 1935\/2004 (Framework) + VO 2023\/2006 (GMP)<\/td><td>Migration restriction, GMP conformity<\/td><\/tr>\n<tr><td>Germany<\/td><td>LFGB \u00a7\u00a7 30\/31<\/td><td>Reference to BfR Recommendation XV &#8220;Silicones&#8221;<\/td><\/tr>\n<tr><td>USA<\/td><td>FDA 21 CFR 177.2600<\/td><td>Extraction test water + n-hexane<\/td><\/tr>\n<tr><td>Pharma\/Medical<\/td><td>USP &lt;87&gt; \/ &lt;88&gt; Class VI, ISO 10993<\/td><td>Biocompatibility (additional)<\/td><\/tr>\n<tr><td>Drinking Water<\/td><td>UBA Guideline for organic materials (KTW-BWGL), W 270 (DVGW)<\/td><td>Stricter migration values than food contact<\/td><\/tr>\n<\/tbody>\n<\/table><\/figure>\n\n\n\n<p><strong>Important:<\/strong> &#8220;Food-safe&#8221; and &#8220;suitable for drinking water&#8221; are not the same. Drinking water applications in Germany additionally require the <strong>KTW-BWGL<\/strong> (Assessment Basis for Organic Materials of the Federal Environment Agency) and \u2013 for microbiologically sensitive applications \u2013 the <strong>DVGW Worksheet W 270<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"hitze-lebensmittel\">Food-safe and heat-resistant \u2013 how do they fit together?<\/h2>\n\n\n\n<p>One of the most common questions is: <em>&#8220;Does silicone remain food-safe even at high temperatures?&#8221;<\/em> The answer: yes \u2013 within the temperature range approved for the respective compound. Standard silicone elastomers for food technology withstand <strong>continuously \u201350 \u00b0C to +200 \u00b0C<\/strong>; short-term, depending on the compound, up to 230 \u00b0C is possible. High-temperature compounds extend the range to about +250 \u00b0C in continuous operation. Above this range, the material slowly changes (increasing hardness, loss of elongation at break), which affects not only mechanical but also migration stability.<\/p>\n\n\n\n<p>This is also why baking molds, baking brushes, or hoses\/tubes in CIP\/SIP cleaning work without problems \u2013 but continuous baking at 250 \u00b0C is only suitable for specially approved compounds. More details on the temperature curve can be found in our article <a href=\"https:\/\/lindemannsilikon.de\/eigenschaften-silikon\/\">Properties of Silicone<\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"praxis\">What processors and auditors really check<\/h2>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>DoC (Declaration of Compliance)<\/strong> with reference to VO 1935\/2004, BfR XV and, if applicable, FDA 21 CFR 177.2600. For pharma, additionally USP Class VI\/ISO 10993.<\/li>\n<li><strong>Migration report<\/strong> with tested simulants, contact conditions (e.g., 10 d\/40 \u00b0C or 2 h\/100 \u00b0C) and results.<\/li>\n<li><strong>Compound identity<\/strong>: material number, cross-linking system, hardness (Shore A), color.<\/li>\n<li><strong>Post-cure status<\/strong>: especially for food and pharma compounds. For pure food contact, 4 h \/ 200 \u00b0C is common.<\/li>\n<li><strong>Traceability<\/strong>: batch, production date, cleanroom class (for pharma).<\/li>\n<\/ol>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"anwendungen\">Typical applications for food-safe silicone<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/lindemannsilikon.de\/silikonschlaeuche-fuer-quetschpumpen-peristaltikpumpen-farbversorgungssysteme\/\">Silicone hoses\/tubes for peristaltic\/squeeze pumps<\/a> in breweries and dairies.<\/li>\n<li>Hoses\/tubes and profiles in <strong>CIP\/SIP systems<\/strong> in the beverage and dairy industry.<\/li>\n<li><strong>Silicone molded parts<\/strong> and gaskets for filling, capping, and packaging systems.<\/li>\n<li><a href=\"https:\/\/lindemannsilikon.de\/silikon-heissluftschlauch\/\">Silicone hot air hoses\/tubes<\/a> for baking lines and food ovens.<\/li>\n<li>Baking molds, scrapers, and spatulas in professional use (commercial kitchens\/bakeries).<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"ausschluss\">When silicone is <em>not<\/em> the right choice<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Prolonged exposure to aliphatic\/aromatic mineral oils or fuels<\/strong> \u2192 better to check fluorosilicone (FVMQ) or other fluoroelastomers.<\/li>\n<li><strong>Steam at very high temperatures for a long time (e.g., autoclaved pharma lines continuously &gt; 135 \u00b0C)<\/strong> \u2192 check specific steam compound.<\/li>\n<li><strong>Mechanically highly abrasive media<\/strong> (abrasive particles) \u2192 silicone is more susceptible to abrasion than, for example, NBR or polyurethane.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"faq\">Frequently Asked Questions (FAQ)<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Is every silicone automatically food-safe?<\/h3>\n\n\n<p>No. Only silicone compounds whose formulation, cross-linking, and processing comply with BfR Recommendation XV (in the EU) or 21 CFR 177.2600 (USA) and for which migration proof and a declaration of conformity are available may be designated as food-safe.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Up to what temperature does food-safe silicone remain stable?<\/h3>\n\n\n<p>Standard compounds for food contact operate continuously from approximately \u201350 \u00b0C to +200 \u00b0C, short-term up to 230 \u00b0C depending on the compound. High-temperature variants reach up to approx. +250 \u00b0C in continuous operation.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">What is the difference between platinum- and peroxide-cured silicone?<\/h3>\n\n\n<p>Platinum-cured (addition-curing) silicones leave no peroxidic cleavage products and are common in food and medical technology. Peroxide-cured silicones require subsequent post-curing to reduce volatile components \u2013 they are technically permissible, but in food practice, they are often replaced by platinum-cured compounds.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Is an FDA approval automatically sufficient for the EU market?<\/h3>\n\n\n<p>No. FDA 21 CFR 177.2600 and BfR Recommendation XV require different tests. For EU food contact, conformity with BfR XV (as well as VO 1935\/2004 and 2023\/2006) is decisive; a pure FDA declaration is not sufficient.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Is silicone suitable for drinking water?<\/h3>\n\n\n<p>Not automatically. Drinking water in Germany is subject to the KTW-BWGL of the Federal Environment Agency and \u2013 for microbiologically relevant components \u2013 the DVGW Worksheet W 270. These tests are stricter than pure food contact; corresponding silicone compounds must be separately approved.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">How do I identify a food-safe silicone component in incoming goods?<\/h3>\n\n\n<p>By three things: (1) the supplier&#8217;s declaration of conformity with reference to BfR XV or 21 CFR 177.2600, (2) the associated migration report, and (3) the clear batch assignment on the delivery note\/label. Optical characteristics (translucency, color) are not a reliable indicator.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"quellen\">Sources<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Bundesinstitut f\u00fcr Risikobewertung (BfR): <a href=\"https:\/\/www.bfr.bund.de\/de\/bfr_empfehlungen_zu_materialien_fuer_den_lebensmittelkontakt-447.html\" rel=\"noopener\" target=\"_blank\">BfR Recommendations on Materials for Food Contact<\/a>, Recommendation XV &#8220;Silicones&#8221;.<\/li>\n<li>U.S. FDA \/ eCFR: <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-B\/part-177\/subpart-C\/section-177.2600\" rel=\"noopener\" target=\"_blank\">21 CFR 177.2600 \u2013 Rubber articles intended for repeated use<\/a>.<\/li>\n<li>Regulation (EC) No. 1935\/2004 on materials and articles intended to come into contact with food.<\/li>\n<li>Regulation (EC) No. 2023\/2006 on good manufacturing practice (GMP) for materials and articles intended to come into contact with food.<\/li>\n<li>LFGB \u2013 Food, Consumer Goods and Feed Code, \u00a7\u00a7 30, 31.<\/li>\n<li>Umweltbundesamt: KTW Assessment Basis for Organic Materials in Drinking Water Contact.<\/li>\n<\/ul>\n\n\n<script type=\"application\/ld+json\">\n{\n  \"@context\": \"https:\/\/schema.org\",\n  \"@graph\": [\n    {\n      \"@type\": \"Article\",\n      \"headline\": \"Is silicone food-safe? 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