{"id":13728,"date":"2026-11-11T11:53:22","date_gmt":"2026-11-11T08:53:22","guid":{"rendered":"https:\/\/www.packlab.gr\/?p=13728"},"modified":"2026-11-12T12:01:19","modified_gmt":"2026-11-12T09:01:19","slug":"efsa-guidance-bisphenols-food-contact-materials","status":"publish","type":"post","link":"https:\/\/www.packlab.gr\/en\/efsa-guidance-bisphenols-food-contact-materials\/","title":{"rendered":"EFSA Sets Data Requirements for Bisphenols Other Than BPA in Food Contact Materials"},"content":{"rendered":"<p style=\"text-align: justify;\">The European Food Safety Authority (EFSA) has published a <a href=\"https:\/\/doi.org\/10.2903\/j.efsa.2026.10368\" target=\"_blank\" rel=\"noopener nofollow\">guidance on the data needed to assess the safety of bisphenols other than BPA<\/a> and their derivatives when used in food contact materials. The guidance follows Regulation (EU) 2024\/3190, which banned BPA in food contact materials and set the conditions for the use of other hazardous bisphenols, as explained in the earlier article on the <a href=\"https:\/\/www.packlab.gr\/en\/eu-ban-on-bisphenol-a-in-food-contact-materials\/\" target=\"_blank\" rel=\"noopener\">EU ban on BPA in food contact materials<\/a>. It now defines what an applicant must submit before such a substance can be authorized for a specific use.<\/p><div id=\"ez-toc-container\" class=\"ez-toc-v2_0_87 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\/efsa-guidance-bisphenols-food-contact-materials\/#Why_the_Guidance_Was_Needed\" >Why the Guidance Was Needed<\/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\/efsa-guidance-bisphenols-food-contact-materials\/#Substances_Within_the_Scope\" >Substances Within the Scope<\/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\/efsa-guidance-bisphenols-food-contact-materials\/#Requirements_at_the_Lowest_Migration_Level\" >Requirements at the Lowest Migration Level<\/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\/efsa-guidance-bisphenols-food-contact-materials\/#Toxicokinetic_Data\" >Toxicokinetic Data<\/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\/efsa-guidance-bisphenols-food-contact-materials\/#Higher_Migration_Levels\" >Higher Migration Levels<\/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\/efsa-guidance-bisphenols-food-contact-materials\/#Migration_Testing_for_Non-Plastic_Materials\" >Migration Testing for Non-Plastic Materials<\/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\/efsa-guidance-bisphenols-food-contact-materials\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Why_the_Guidance_Was_Needed\"><\/span><strong>Why the Guidance Was Needed<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Under Regulation (EU) 2024\/3190, hazardous bisphenols may be used in food contact materials only if their use for a specific application has been authorized. Article 6(4) of the Regulation required EFSA to publish the information needed for that assessment, in cooperation with the European Chemicals Agency (ECHA). EFSA&#8217;s FCM Panel took on the task in July 2025, with a deadline of 19 January 2027.<\/p>\n<p style=\"text-align: justify;\">The guidance complements the existing EFSA Note for Guidance for substances used in plastic food contact materials, which dates from 2008. It adds specific toxicological requirements and, for non-plastic materials, guidance on migration testing.<\/p>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Substances_Within_the_Scope\"><\/span><strong>Substances Within the Scope<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">The guidance applies to bisphenols and bisphenol derivatives with a harmonized classification under the CLP Regulation (EC) No 1272\/2008 as carcinogenic, mutagenic or toxic to reproduction (category 1A or 1B) or as endocrine disruptors for human health (category 1).<\/p>\n<p style=\"text-align: justify;\">EFSA also states that the same data should be provided for bisphenols that are not classified as hazardous. The aim is to prevent regrettable substitution, where BPA is replaced by a structurally similar substance with comparable effects.<\/p>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Requirements_at_the_Lowest_Migration_Level\"><\/span><strong>Requirements at the Lowest Migration Level<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">For most substances in plastic food contact materials, migration below 0.05 mg\/kg food only requires genotoxicity data. For hazardous bisphenols, the guidance asks for considerably more. EFSA bases this on its 2023 re-evaluation of BPA, which identified immune and reproductive effects at very low exposure and on data indicating that other bisphenols may act at similar or lower levels.<\/p>\n<p style=\"text-align: justify;\">The core requirement is an Extended One-Generation Reproductive Toxicity (EOGRT) study according to OECD Test Guideline 443, with the pre-mating exposure period extended from at least two weeks to at least ten. EFSA also lists additional parameters for immunotoxicity and metabolic effects, including immunoglobulins, inflammation markers, lymphocyte subpopulations and uric acid levels.<\/p>\n<p style=\"text-align: justify;\">Where toxicity studies already exist but do not cover these endpoints, applicants can fill the gaps with a weight-of-evidence approach that combines animal data with in vitro and in silico methods. Studies must follow good laboratory practice and OECD test guidelines where available. Data may be omitted only with scientific justification.<\/p>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: justify;\"><strong><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-large wp-image-13725\" src=\"https:\/\/www.packlab.gr\/wp-content\/uploads\/2026\/11\/efsa-article-1024x768.png\" alt=\"Plastic food storage containers and open metal food cans, food contact materials covered by EFSA guidance on bisphenols\" width=\"1024\" height=\"768\" srcset=\"https:\/\/www.packlab.gr\/wp-content\/uploads\/2026\/11\/efsa-article-1024x768.png 1024w, https:\/\/www.packlab.gr\/wp-content\/uploads\/2026\/11\/efsa-article-300x225.png 300w, https:\/\/www.packlab.gr\/wp-content\/uploads\/2026\/11\/efsa-article-768x576.png 768w, https:\/\/www.packlab.gr\/wp-content\/uploads\/2026\/11\/efsa-article.png 1200w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/strong><\/h3>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Toxicokinetic_Data\"><\/span><strong>Toxicokinetic Data<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">The guidance requests three studies on how the substance behaves in the body: an in vivo study on absorption, distribution, metabolism and excretion, an in vitro comparison of metabolism in rats and humans and an in vitro study on intrinsic clearance. These data support physiologically based kinetic models, which help translate laboratory results into estimates of human exposure.<\/p>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Higher_Migration_Levels\"><\/span><strong>Higher Migration Levels<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">For migration between 0.05 and 5 mg\/kg food, no further toxicological data are needed, since the extended EOGRT study is considered to cover the 90-day study normally required. Above 5 mg\/kg food, applicants must also provide the long-term toxicity and carcinogenicity data set out in the 2008 Note for Guidance.<\/p>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Migration_Testing_for_Non-Plastic_Materials\"><\/span><strong>Migration Testing for Non-Plastic Materials<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Regulation (EU) 2024\/3190 also covers materials other than plastics, such as coatings, varnishes, printing inks and adhesives. Since only plastics have harmonized EU testing conditions, the guidance recommends following the technical guidelines of the Commission&#8217;s Joint Research Centre, including those for kitchenware or national guidance where no JRC guideline exists. When results from food and food simulants differ, the results obtained in food take precedence.<\/p>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span><strong>Conclusion<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">The guidance makes clear that authorization of a hazardous bisphenol for food contact will require an extensive toxicological data package, even at low migration levels. In practice, this sets a high bar for bringing BPA alternatives of this type to market and extends the same expectations to non-classified bisphenols. For manufacturers, it is a further reason to review the substances in their formulations and the documentation they receive from suppliers.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>EFSA has published guidance on the data needed to assess the safety of bisphenols other than BPA in food contact materials, following Regulation (EU) 2024\/3190, with extended toxicological requirements even at the lowest migration level.<\/p>\n","protected":false},"author":8,"featured_media":13725,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[28,540],"tags":[],"class_list":["post-13728","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en","category-regulations-policy-en","category-28","category-540","description-off"],"_links":{"self":[{"href":"https:\/\/www.packlab.gr\/en\/wp-json\/wp\/v2\/posts\/13728","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\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/www.packlab.gr\/en\/wp-json\/wp\/v2\/comments?post=13728"}],"version-history":[{"count":2,"href":"https:\/\/www.packlab.gr\/en\/wp-json\/wp\/v2\/posts\/13728\/revisions"}],"predecessor-version":[{"id":13730,"href":"https:\/\/www.packlab.gr\/en\/wp-json\/wp\/v2\/posts\/13728\/revisions\/13730"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packlab.gr\/en\/wp-json\/wp\/v2\/media\/13725"}],"wp:attachment":[{"href":"https:\/\/www.packlab.gr\/en\/wp-json\/wp\/v2\/media?parent=13728"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.packlab.gr\/en\/wp-json\/wp\/v2\/categories?post=13728"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.packlab.gr\/en\/wp-json\/wp\/v2\/tags?post=13728"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}