{"id":13686,"date":"2026-11-04T11:01:24","date_gmt":"2026-11-04T08:01:24","guid":{"rendered":"https:\/\/www.packlab.gr\/?p=13686"},"modified":"2026-11-04T11:01:24","modified_gmt":"2026-11-04T08:01:24","slug":"eu-10-2011-amendment-regulation-2026-2412-new-substances","status":"publish","type":"post","link":"https:\/\/www.packlab.gr\/en\/eu-10-2011-amendment-regulation-2026-2412-new-substances\/","title":{"rendered":"EU 10\/2011 Amendment: Regulation 2026\/2412 Authorises Four New Substances for Food Contact Plastics"},"content":{"rendered":"<p style=\"text-align: justify;\">On 29 October 2026, the European Commission published <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2026\/2412\/oj\" target=\"_blank\" rel=\"noopener nofollow\">Regulation (EU) 2026\/2412<\/a> in the Official Journal, adding four substances to the Union list of Annex I of Regulation (EU) No 10\/2011. The authorizations follow positive EFSA opinions issued between 2021 and 2024 and each comes with specific conditions on the polymer, the amount used, the type of food or the migration allowed. The Regulation enters into force on <strong>18 November 2026<\/strong>. The update is targeted: it opens new options for specific materials and does not change the rules for substances already in 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\/eu-10-2011-amendment-regulation-2026-2412-new-substances\/#The_Four_New_Substances\" >The Four New Substances<\/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\/eu-10-2011-amendment-regulation-2026-2412-new-substances\/#Notes_on_Verification_of_Compliance\" >Notes on Verification of Compliance<\/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\/eu-10-2011-amendment-regulation-2026-2412-new-substances\/#Who_Is_Affected\" >Who Is Affected<\/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\/eu-10-2011-amendment-regulation-2026-2412-new-substances\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"The_Four_New_Substances\"><\/span><strong>The Four New Substances<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ol style=\"text-align: justify;\">\n<li><strong>Chopped carbon fibres from carbonized polyacrylonitrile (FCM No 1086)<\/strong><\/li>\n<\/ol>\n<p style=\"text-align: justify;\">The fibres are authorized as a filler or reinforcement in polyetheretherketone (PEEK) only, at up to <strong>40 % w\/w<\/strong>. They must contain at least <strong>95 %<\/strong> carbon and must not be in the nanoscale in any dimension (diameter above 100 nm). Under these conditions, EFSA found no safety concern for any type of food or condition of use.<\/p>\n<p>&nbsp;<\/p>\n<ol style=\"text-align: justify;\" start=\"2\">\n<li><strong>Nano precipitated calcium carbonate, uncoated (FCM No 1087)<\/strong><\/li>\n<\/ol>\n<p style=\"text-align: justify;\">This filler can be used in all types of polymers and for all types of food, with one exception: it must not be used in materials intended for contact with infant formula. EFSA concluded that the nanoparticles dissolve quickly under simulated gastric conditions, but it could not reach a conclusion on infant formula. The authorization is limited to uncoated particles, as coated particles were not covered by the application and could behave differently.<\/p>\n<p style=\"text-align: justify;\"><strong>\u00a0<\/strong><\/p>\n<ol style=\"text-align: justify;\" start=\"3\">\n<li><strong>Poly(2-hydroxypropanoic acid), n-octyl\/n-decyl esters (FCM No 1088)<\/strong><\/li>\n<\/ol>\n<p style=\"text-align: justify;\">This additive is authorized for polylactic acid (PLA) only, under strict conditions:<\/p>\n<ul style=\"text-align: justify;\">\n<li>up to <strong>15 % w\/w<\/strong>, in PLA that contains no starch (FCM No 564) or other additives with a similar function that could increase migration<\/li>\n<li>for contact of up to <strong>10 days<\/strong> <strong>at 40 \u00b0C<\/strong><\/li>\n<li>only with water (food category 01.01), fresh or chilled fruit (04.01), fresh or chilled vegetables (04.04) and vinegar (08.01)<\/li>\n<li>with a specific migration limit (SML) of <strong>05 mg\/kg food<\/strong><\/li>\n<\/ul>\n<p style=\"text-align: justify;\">The applicant intends to use the substance in single-use films, trays and containers for fresh produce and beverages.<\/p>\n<p>&nbsp;<\/p>\n<ol style=\"text-align: justify;\" start=\"4\">\n<li><strong>Mixture of 1,9-nonanediamine (NMDA) and 2-methyl-1,8-octanediamine (MODA) (FCM No 1090)<\/strong><\/li>\n<\/ol>\n<p style=\"text-align: justify;\">The mixture is authorized as a comonomer with terephthalic acid in the manufacture of polyamide. The sum of NMDA and MODA migration must not exceed <strong>0.05 mg\/kg<\/strong> food and migration of the related oligomer fraction below 1,000 Da must not exceed <strong>5 mg\/kg<\/strong> food. Its use is excluded for materials in contact with infant formula and human milk.<\/p>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: justify;\"><strong><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-large wp-image-13682\" src=\"https:\/\/www.packlab.gr\/wp-content\/uploads\/2026\/11\/2-3-1024x768.png\" alt=\"White, black and clear plastic food trays on a blue background with the text \u201cEU 2026\/2412\u201d, illustrating the amendment to Regulation 10\/2011 authorising four new substances\" width=\"1024\" height=\"768\" srcset=\"https:\/\/www.packlab.gr\/wp-content\/uploads\/2026\/11\/2-3-1024x768.png 1024w, https:\/\/www.packlab.gr\/wp-content\/uploads\/2026\/11\/2-3-300x225.png 300w, https:\/\/www.packlab.gr\/wp-content\/uploads\/2026\/11\/2-3-768x576.png 768w, https:\/\/www.packlab.gr\/wp-content\/uploads\/2026\/11\/2-3.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=\"Notes_on_Verification_of_Compliance\"><\/span><strong>Notes on Verification of Compliance<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">The Regulation also adds two notes to Table 3 of Annex I, which guide how compliance should be tested:<\/p>\n<ul style=\"text-align: justify;\">\n<li><strong>Nano calcium carbonate (FCM 1087):<\/strong> there is a risk of exceeding the overall migration limit in contact with acidic foods. EFSA observed that overall migration into acidic foods from materials containing the substance may exceed the limit of Article 12 of Regulation 10\/2011.<\/li>\n<li><strong>PLA additive (FCM 1088):<\/strong> there is a risk of exceeding the SML when food simulants other than simulant B (3 % acetic acid) are used. According to EFSA, the SML was exceeded in tests with 10 % ethanol, 95 % ethanol and isooctane and when starch was added to the PLA.<\/li>\n<\/ul>\n<p style=\"text-align: justify;\">These notes matter for test planning. For materials containing these substances, the choice of simulants and test conditions should reflect the specific risks identified.<\/p>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Who_Is_Affected\"><\/span><strong>Who Is Affected<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">The Regulation expands the list of authorized substances. It does not introduce new restrictions on substances already in use and it contains no transitional provisions. Companies that do not use these four substances do not need to change anything.<\/p>\n<p style=\"text-align: justify;\">It is relevant mainly to:<\/p>\n<ul style=\"text-align: justify;\">\n<li><strong>manufacturers of PEEK components<\/strong> for food processing equipment, who can now use carbon fibre reinforcement<\/li>\n<li><strong>converters using mineral fillers<\/strong>, who can now use uncoated nano calcium carbonate, provided their products are not intended for infant formula and their testing covers acidic foods<\/li>\n<li><strong>producers of PLA packaging<\/strong> for fresh fruit, vegetables and water, who can now use the new additive under the specified conditions<\/li>\n<li><strong>polyamide manufacturers<\/strong>, who can now use the NMDA\/MODA mixture, with exclusions for infant formula and human milk.<\/li>\n<\/ul>\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;\">Regulation 2026\/2412 is a limited update to the Union list, relevant only to companies that plan to use these four substances. For them, the conditions of use are narrow, especially for the PLA additive, and migration testing should take into account the verification notes added to Annex I.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Regulation (EU) 2026\/2412 amends Regulation 10\/2011, adding four substances to its Union list for PEEK, PLA, polyamide and mineral-filled plastics, each with specific conditions, migration limits and exclusions for infant formula.<\/p>\n","protected":false},"author":4,"featured_media":13682,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[28,540],"tags":[],"class_list":["post-13686","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\/13686","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=13686"}],"version-history":[{"count":2,"href":"https:\/\/www.packlab.gr\/en\/wp-json\/wp\/v2\/posts\/13686\/revisions"}],"predecessor-version":[{"id":13688,"href":"https:\/\/www.packlab.gr\/en\/wp-json\/wp\/v2\/posts\/13686\/revisions\/13688"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packlab.gr\/en\/wp-json\/wp\/v2\/media\/13682"}],"wp:attachment":[{"href":"https:\/\/www.packlab.gr\/en\/wp-json\/wp\/v2\/media?parent=13686"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.packlab.gr\/en\/wp-json\/wp\/v2\/categories?post=13686"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.packlab.gr\/en\/wp-json\/wp\/v2\/tags?post=13686"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}