On 27 April 2026, the European Commission published Commission Regulation (EU) 2026\/909, amending Annexes II and III of the EU Cosmetics Regulation (EC) No 1223\/2009. The regulation restricts or prohibits twelve substances following updated Scientific Committee on Consumer Safety (SCCS) opinions raising concerns about endocrine-disrupting and genotoxic potential.<\/p>\n\n\n\n
Two compliance dates apply: only compliant products may be placed on the EU market from 1 January 2027, and only compliant products may be made available on the EU market at all from 1 July 2028. Companies with lead times for reformulation, retesting and CPSR updates have roughly five months from today before the first deadline takes effect.<\/p>\n\n\n\n
The rule affects any company formulating with the twelve named substances, which span fragrance and flavour ingredients, UV-filter-adjacent compounds, hair-dye components, and antimicrobial or skin-conditioning agents such as zinc salts, so exposure is broader than a single product category.<\/p>\n\n\n\n
This is the second major update to the Cosmetics Regulation’s ingredient annexes in 2026. Commission Regulation (EU) 2026\/78, known as Omnibus VIII, already removed 15 CMR-classified (carcinogenic, mutagenic or toxic to reproduction) substances from Annex II with no transition period at all, effective 1 May 2026. Companies that have not yet reviewed formulas against both updates risk running two separate compliance projects instead of one combined review.<\/p>\n\n\n\n
The regulation covers twelve substances: benzyl salicylate, triphenyl phosphate, ammonium silver zinc aluminium silicate, aluminium, water-soluble zinc salts (including zinc acetate, zinc chloride, zinc gluconate, zinc glutamate, zinc citrate and zinc sulphate), acetylated vetiver oil, citral (together with its constituents geranial and neral), HC Blue No 18, HC Red No 18, HC Yellow No 16, hydroxypropyl-p-phenylenediamine and its dihydrochloride salt, and DHHB (diethylamino hydroxybenzoyl hexyl benzoate).<\/p>\n\n\n\n
Annex II is a prohibition list: a substance listed there may not be used in cosmetic products at all, regardless of concentration or product type. Annex III is a restricted-use list: a substance remains permitted, but only under the specific conditions stated, typically a maximum concentration, a defined product type, or required warning wording.<\/p>\n\n\n\n
Under Regulation (EU) 2026\/909, triphenyl phosphate moves into Annex II, so it must be removed from formulas entirely. Benzyl salicylate stays in Annex III, so the response is reformulation to a lower concentration and updated documentation, not removal. Confirming which of these two situations applies to your formula is the first thing to check, since it determines whether the fix is “reformulate” or “remove.”<\/p>\n\n\n\n
Several of the twelve substances were previously permitted or in routine use under existing Annex III conditions. Restrictions like these typically follow a new or updated SCCS opinion, reassessing a substance against newer toxicological data, updated exposure estimates, or a revised hazard classification under the EU’s CLP (Classification, Labelling and Packaging) framework, which can trigger a “CMR” reclassification that then feeds into the Cosmetics Regulation. This is a routine, ongoing part of how the EU annexes are maintained, not a signal that the earlier assessment was flawed; it does mean formulators should expect periodic Annex updates and treat ingredient monitoring as a continuous task rather than a one-time check.<\/p>\n\n\n\n
The goal across all of this: one consistent regulatory record across formula, label and safety file, rather than separate answers from the lab, the formulator and the safety assessor.<\/p>\n\n\n\n
With the first compliance date on 1 January 2027 and reformulation timelines often running longer than the months remaining, the fastest way to know your exposure is a targeted analytical screen against the updated Annex II and Annex III entries.<\/p>\n\n\n\n
Request an ingredient restriction check against Regulation (EU) 2026\/909 from Makrolife Biotech.<\/strong><\/p>\n\n\n\n A second Annex update in the same year On 27 April 2026, the European Commission published Commission Regulation (EU) 2026\/909, amending Annexes II and III of the EU\u2026<\/p>\n","protected":false},"author":2,"featured_media":247,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[46],"tags":[51,49,47,54,52,53,55,17,50,48],"class_list":["post-246","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulations","tag-annex-ii-annex-iii-cosmetics-regulation","tag-benzyl-salicylate-concentration-limit","tag-cosmetic-ingredient-restrictions-2027","tag-cosmetic-ingredient-testing-germany","tag-cpsr-reformulation","tag-eu-cosmetics-regulation-2026","tag-eu-cosmetics-regulation-2026-909","tag-regulation","tag-sccs-opinion-cosmetics","tag-triphenyl-phosphate-ban-cosmetics"],"_links":{"self":[{"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/posts\/246","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/comments?post=246"}],"version-history":[{"count":1,"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/posts\/246\/revisions"}],"predecessor-version":[{"id":248,"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/posts\/246\/revisions\/248"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/media\/247"}],"wp:attachment":[{"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/media?parent=246"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/categories?post=246"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/tags?post=246"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Sources<\/h2>\n\n\n\n
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