{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T19:00:53Z","timestamp":1791399653438,"version":"4.3.3"},"reference-count":59,"publisher":"Oxford University Press (OUP)","license":[{"start":{"date-parts":[[2026,8,5]],"date-time":"2026-08-05T00:00:00Z","timestamp":1785888000000},"content-version":"am","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Risks of Chemicals","award":["101057014"],"award-info":[{"award-number":["101057014"]}]},{"DOI":"10.13039\/501100000855","name":"University of Birmingham\u2019s","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100000855","id-type":"DOI","asserted-by":"crossref"}]},{"name":"UK Research and Innovation Horizon Europe Guarantee Fund","award":["10045979"],"award-info":[{"award-number":["10045979"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Lip products occupy a regulatory blind spot. Classified as cosmetics for external application across all major jurisdictions, lip products have two distinct adverse outcome pathways: (a) cutaneous absorption via lip tissue with significantly diminished barrier function and (b) oral ingestion documented at levels reaching half a kilogram annually for high-frequency users. We present a comparative analysis of how the United States, European Union (EU), United Kingdom, Canada, China, and South Korea regulate lip products, revealing a systemic gap in how regulations address their actual exposure profile. Three critical gaps are common across all frameworks: definitional miscategorization of the exposure profile; the absence of appropriate safety assessment for either the ingestion or lip tissue absorption pathway; and testing duration requirements that are absent in the majority of frameworks and, where they exist, capped at subchronic endpoints that do not reflect continuous real-world use extending far beyond 90\u2009days. Baseline exposure data underpinning global safety assessments were collected from 2003 to 2005 and predate contemporary lip product categories; contemporary studies document 95th-percentile lip balm consumption at 1,270\u2009mg\/day, a 14.6-fold increase over regulatory baselines. Two regulatory paradoxes within the EU crystallize the classificatory failure: Titanium dioxide, banned as a food additive over oral ingestion genotoxicity concerns, remains unrestricted in lip cosmetics with an identical ingestion pathway; microplastics are restricted in lip products under EU chemicals regulation because of environmental release through human ingestion, while the Cosmetics Regulation assesses them under dermal parameters. This demonstrates that regulatory sophistication cannot overcome classificatory error and that meaningful reform requires updated, population-specific exposure studies reflecting contemporary usage patterns, product categories, and consumer demographics. We recommend development of lip-appropriate assessment methodology via validated nonanimal methods\u2014within existing cosmetic regulatory frameworks, without product reclassification\u2014and the potential extension of the food-grade ingredient safety principles accepted in industry voluntary guidance to all lip product ingredient categories.<\/jats:p>","DOI":"10.1093\/inteam\/vjag129","type":"journal-article","created":{"date-parts":[[2026,8,5]],"date-time":"2026-08-05T08:02:00Z","timestamp":1785916920000},"source":"Crossref","is-referenced-by-count":1,"title":["Global framework for lip product safety: A review of the regulatory blind spot in the modern market"],"prefix":"10.1093","author":[{"given":"Laura","family":"DiGirolamo","sequence":"first","affiliation":[{"name":"Lip Service Alliance , San Pedro, CA,","place":["United States"]},{"name":"YOM Beauty Ltd , London,","place":["United 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