{"id":9827,"date":"2025-08-04T10:32:20","date_gmt":"2025-08-04T07:32:20","guid":{"rendered":"https:\/\/www.packlab.gr\/?p=9827"},"modified":"2025-09-03T10:50:57","modified_gmt":"2025-09-03T07:50:57","slug":"food-contact-compliance-for-packaging","status":"publish","type":"post","link":"https:\/\/www.packlab.gr\/en\/food-contact-compliance-for-packaging\/","title":{"rendered":"Food Contact Compliance: US and EU Regulations Compared"},"content":{"rendered":"<p style=\"text-align: justify;\">In 2025, the U.S. Food and Drug Administration (FDA) is undergoing one of its most transformative regulatory shifts in decades. Prompted by public health concerns and administrative directives, changes in oversight of <strong>food contact materials (FCMs)<\/strong> now focus on post-market reassessment, elimination of loopholes, and alignment with best international practices. These reforms, anchored in a <strong>historic FDA reorganization<\/strong> and the reevaluation of the <strong>Generally Recognized as Safe (GRAS)<\/strong> framework, offer key comparisons with the European Union&#8217;s highly structured regulatory model.<\/p><div id=\"ez-toc-container\" class=\"ez-toc-v2_0_82_2 ez-toc-wrap-center counter-hierarchy ez-toc-counter ez-toc-custom ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title ez-toc-toggle\" style=\"cursor:pointer\">TABLE OF CONTENTS<\/p>\n<span class=\"ez-toc-title-toggle\"><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.packlab.gr\/en\/food-contact-compliance-for-packaging\/#FDAs_Human_Foods_Program_Centralized_Oversight_for_Food_Safety\" >FDA\u2019s Human Foods Program: Centralized Oversight for Food Safety<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.packlab.gr\/en\/food-contact-compliance-for-packaging\/#GRAS_Reform_Ending_Self-Affirmation_and_Strengthening_Transparency\" >GRAS Reform: Ending Self-Affirmation and Strengthening Transparency<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.packlab.gr\/en\/food-contact-compliance-for-packaging\/#US_Code_of_Federal_Regulations_21_CFR_vs_EU_Compliance_Standards\" >U.S. Code of Federal Regulations (21 CFR) vs. EU Compliance Standards<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.packlab.gr\/en\/food-contact-compliance-for-packaging\/#Testing_Requirements_Resin_Extraction_vs_Simulant_Migration\" >Testing Requirements: Resin Extraction vs. Simulant Migration<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.packlab.gr\/en\/food-contact-compliance-for-packaging\/#State-Level_Influence_California_Proposition_65\" >State-Level Influence: California Proposition 65<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.packlab.gr\/en\/food-contact-compliance-for-packaging\/#Recycled_Plastics_FDAs_Non-Objection_Letters_vs_EU_Authorization\" >Recycled Plastics: FDA&#8217;s Non-Objection Letters vs. EU Authorization<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.packlab.gr\/en\/food-contact-compliance-for-packaging\/#Conclusion_Converging_Goals_Diverging_Methods\" >Conclusion: Converging Goals, Diverging Methods<\/a><\/li><\/ul><\/nav><\/div>\n\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: left;\"><span class=\"ez-toc-section\" id=\"FDAs_Human_Foods_Program_Centralized_Oversight_for_Food_Safety\"><\/span><strong>FDA\u2019s Human Foods Program: Centralized Oversight for Food Safety<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">In October 2024, the FDA implemented its largest reorganization in recent history by <a href=\"https:\/\/www.fda.gov\/about-fda\/fda-organization\/fda-modernization-efforts-establishing-unified-human-foods-program-new-model-field-operations-and\" target=\"_blank\" rel=\"noopener nofollow\">launching the <strong>Human Foods Program (HFP)<\/strong><\/a>. This action consolidated food safety responsibilities previously scattered across the Center for Food Safety and Applied Nutrition (CFSAN), the Office of Food Policy and Response, and parts of the Office of Regulatory Affairs.<\/p>\n<p style=\"text-align: justify;\">The restructuring was driven by recommendations from the <strong>Reagan-Udall Foundation<\/strong> and internal audits after the 2022 infant formula crisis. It <a href=\"https:\/\/www.reuters.com\/world\/us\/us-fda-set-reorganize-its-food-division-starting-october-2024-05-30\/\" target=\"_blank\" rel=\"noopener nofollow\">emphasizes<\/a> risk-based decision-making and systematic post-market chemical assessments, similar to how the EU\u2019s <strong>European Food Safety Authority (EFSA)<\/strong> manages the lifecycle of food-contact substances.<\/p>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: left;\"><span class=\"ez-toc-section\" id=\"GRAS_Reform_Ending_Self-Affirmation_and_Strengthening_Transparency\"><\/span><strong>GRAS Reform: Ending Self-Affirmation and Strengthening Transparency<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">On <strong>March 10, 2025<\/strong>, HHS Secretary Robert F. Kennedy Jr. directed the FDA to explore rulemaking that would <strong>eliminate the self-affirmed GRAS pathway<\/strong>, a regulatory process long criticized for allowing companies to determine safety without FDA review.<\/p>\n<p style=\"text-align: justify;\">This decision aligns with concerns raised by consumer safety groups and media investigations, including <a href=\"https:\/\/www.washingtonpost.com\/health\/2025\/03\/11\/rfk-food-gras-loophole-fda\/\" target=\"_blank\" rel=\"noopener nofollow\"><em>The Washington Post<\/em>\u2019s report<\/a> that the GRAS process enabled food additives to bypass independent scrutiny. In contrast, the <strong>EU mandates EFSA safety assessments<\/strong> for all substances intended for food contact, offering a more centralized and publicly accountable process.<\/p>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: left;\"><span class=\"ez-toc-section\" id=\"US_Code_of_Federal_Regulations_21_CFR_vs_EU_Compliance_Standards\"><\/span><strong>U.S. Code of Federal Regulations (21 CFR) vs. EU Compliance Standards<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Food contact regulation in the U.S. is governed under <strong>Title 21 of the Code of Federal Regulations (CFR)<\/strong>, particularly Parts <strong>170\u2013199<\/strong>, which categorize additives by function and material type:<\/p>\n<ul style=\"text-align: justify;\">\n<li><strong>\u00a7177.1520<\/strong>: Olefin polymers (e.g., polyethylene, polypropylene)<\/li>\n<li><strong>\u00a7177.1630<\/strong>: PET polymers<\/li>\n<li><strong>\u00a7175.105 and \u00a7178.2010<\/strong>: Adhesives and stabilizers<\/li>\n<\/ul>\n<p style=\"text-align: justify;\">Each material has unique extraction limits and permitted additive lists. Unlike the <strong>EU\u2019s unified positive list<\/strong> under <strong>Regulation (EU) No. 10\/2011<\/strong>, the U.S. system <strong>does<\/strong> <strong>not allow automatic cross-application<\/strong> of approvals between materials.<\/p>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: left;\"><strong><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-large wp-image-9820\" src=\"https:\/\/www.packlab.gr\/wp-content\/uploads\/2025\/08\/US-vs-EU-Food-Contact-Rules-2025-2-1024x576.png\" alt=\"Food Contact Compliance for Packaging Manufacturers: U.S. and EU Regulations Compared\" width=\"1024\" height=\"576\" srcset=\"https:\/\/www.packlab.gr\/wp-content\/uploads\/2025\/08\/US-vs-EU-Food-Contact-Rules-2025-2-1024x576.png 1024w, https:\/\/www.packlab.gr\/wp-content\/uploads\/2025\/08\/US-vs-EU-Food-Contact-Rules-2025-2-300x169.png 300w, https:\/\/www.packlab.gr\/wp-content\/uploads\/2025\/08\/US-vs-EU-Food-Contact-Rules-2025-2-768x432.png 768w, https:\/\/www.packlab.gr\/wp-content\/uploads\/2025\/08\/US-vs-EU-Food-Contact-Rules-2025-2-1536x864.png 1536w, https:\/\/www.packlab.gr\/wp-content\/uploads\/2025\/08\/US-vs-EU-Food-Contact-Rules-2025-2.png 1920w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/strong><\/h3>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: left;\"><span class=\"ez-toc-section\" id=\"Testing_Requirements_Resin_Extraction_vs_Simulant_Migration\"><\/span><strong>Testing Requirements: Resin Extraction vs. Simulant Migration<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">The FDA typically requires extraction testing on raw polymers using solvents like <strong>hexane or xylene<\/strong>, without evaluating the final consumer-facing material. For example, <strong>\u00a7177.1520<\/strong> limits hexane extractables in <strong>polypropylene to 6.4 % by weight<\/strong>.<\/p>\n<p style=\"text-align: justify;\">By contrast, the <strong>EU mandates overall and specific migration testing<\/strong> using <strong>food simulants<\/strong>, under actual or worst-case conditions, ensuring direct consumer safety.<\/p>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: left;\"><span class=\"ez-toc-section\" id=\"State-Level_Influence_California_Proposition_65\"><\/span><strong>State-Level Influence: California Proposition 65<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">California\u2019s <a href=\"https:\/\/www.oehha.ca.gov\/proposition-65\/general-info\/proposition-65-plain-language\" target=\"_blank\" rel=\"noopener nofollow\"><strong>Proposition 65<\/strong><\/a> adds another layer of regulatory complexity. It requires warning labels for any products containing substances known to cause cancer or reproductive harm, including FCM-related pigments and adhesives. <strong>While not exclusive to food, it affects many food packaging manufacturers<\/strong> seeking national distribution.<\/p>\n<p style=\"text-align: justify;\">This state-level framework mimics the <strong>EU\u2019s REACH legislation<\/strong>, where companies must track and disclose hazardous substances (SVHCs) used in their products.<\/p>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: left;\"><span class=\"ez-toc-section\" id=\"Recycled_Plastics_FDAs_Non-Objection_Letters_vs_EU_Authorization\"><\/span><strong>Recycled Plastics: FDA&#8217;s Non-Objection Letters vs. EU Authorization<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">The FDA allows use of <strong>recycled plastic in food packaging<\/strong> if the producer receives a <strong>No Objection Letter (NOL)<\/strong>, indicating the process poses no health risk. However, participation is <strong>voluntary<\/strong> (<a href=\"https:\/\/www.fda.gov\/food\/packaging-food-contact-substances-fcs\/recycled-plastics-food-packaging\" target=\"_blank\" rel=\"noopener nofollow\">FDA Recycled Plastics Guidance<\/a>).<\/p>\n<p style=\"text-align: justify;\">In contrast, the EU mandates strict approval of recycled materials under <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2022\/1616\/oj\/eng\" target=\"_blank\" rel=\"noopener nofollow\"><strong>Regulation (EU) 2022\/1616<\/strong><\/a>, with comprehensive controls on traceability and decontamination.<\/p>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: left;\"><span class=\"ez-toc-section\" id=\"Conclusion_Converging_Goals_Diverging_Methods\"><\/span><strong>Conclusion: Converging Goals, Diverging Methods<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">The U.S. regulatory approach is rapidly evolving. With the FDA\u2019s restructuring and a push to close the GRAS loophole, 2025 marks a pivot toward transparency, accountability, and <strong>partial alignment with EU-like oversight<\/strong>. However, significant differences remain, particularly in testing protocols, legal frameworks, and the structure of substance authorizations.<\/p>\n<p style=\"text-align: justify;\">For international companies, <strong>compliance in one region does not guarantee approval in another<\/strong>. Understanding both U.S. and EU regulatory landscapes is essential for navigating the complex, increasingly health-conscious world of food contact materials.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In 2025, the U.S. Food and Drug Administration (FDA) is undergoing one of its most transformative regulatory shifts in decades. Prompted by public health concerns and administrative directives, changes in oversight of food contact materials (FCMs) now focus on post-market reassessment, elimination of loopholes, and alignment with best international practices. These reforms, anchored in a&hellip;<\/p>\n","protected":false},"author":4,"featured_media":9830,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[28,545,540],"tags":[],"class_list":["post-9827","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en","category-packaging-legislation-en","category-regulations-policy-en","category-28","category-545","category-540","description-off"],"_links":{"self":[{"href":"https:\/\/www.packlab.gr\/en\/wp-json\/wp\/v2\/posts\/9827","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packlab.gr\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.packlab.gr\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.packlab.gr\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.packlab.gr\/en\/wp-json\/wp\/v2\/comments?post=9827"}],"version-history":[{"count":3,"href":"https:\/\/www.packlab.gr\/en\/wp-json\/wp\/v2\/posts\/9827\/revisions"}],"predecessor-version":[{"id":9832,"href":"https:\/\/www.packlab.gr\/en\/wp-json\/wp\/v2\/posts\/9827\/revisions\/9832"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packlab.gr\/en\/wp-json\/wp\/v2\/media\/9830"}],"wp:attachment":[{"href":"https:\/\/www.packlab.gr\/en\/wp-json\/wp\/v2\/media?parent=9827"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.packlab.gr\/en\/wp-json\/wp\/v2\/categories?post=9827"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.packlab.gr\/en\/wp-json\/wp\/v2\/tags?post=9827"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}