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==Safety evaluation== {{further|Environmental impact of pharmaceuticals and personal care products}} {{Update|section|date=May 2025}} In the United States, cosmetic products and ingredients do not need FDA premarket approval, with the exception of color additives, but manufacturers are required to assure safety of the products.<ref name="fda-reg">{{cite web| url=https://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074162.htm| archive-url=https://web.archive.org/web/20140401084712/http://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074162.htm| url-status=dead| archive-date=1 April 2014| title=FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated|publisher=US Food and Drug Administration|date=2 March 2022|access-date=4 May 2025}}</ref> The EU and other regulatory agencies around the world also have stringent regulations.<ref>{{cite web|url=https://europa.eu/legislation_summaries/consumers/product_labelling_and_packaging/co0013_en.htm|title=EUR-Lex β co0013 β EN β EUR-Lex|work=europa.eu|access-date=2022-02-21|archive-date=2015-05-08|archive-url=https://web.archive.org/web/20150508131613/http://europa.eu/legislation_summaries/consumers/product_labelling_and_packaging/co0013_en.htm|url-status=live}}</ref> The FDA provides surveillance of cosmetics products, and exercises enforcement against companies that break manufacturing, labeling or marketing laws on cosmetic products, such as by issuing [[FDA warning letter|warning letters]] to companies making unapproved [[health claim]]s.<ref name="fda-cosm">{{cite web |title=Cosmetics Labeling Claims |url=https://www.fda.gov/cosmetics/cosmetics-labeling/cosmetics-labeling-claims |archive-url=https://web.archive.org/web/20190912074451/https://www.fda.gov/cosmetics/cosmetics-labeling/cosmetics-labeling-claims |url-status=dead |archive-date=12 September 2019 |publisher=US Food and Drug Administration |access-date=5 May 2025 |date=21 November 2021}}</ref> [[File:Epikutanni-test.jpg|thumb|[[Patch test]]]] [[Perfume]]s are widely used in consumer products. Studies concluded from [[patch test]]ing show [[aroma compound|fragrances]] contain some ingredients which may cause [[allergic reaction]]s.<ref name="Synthetic_Fragrances">{{cite journal |last1=Frosch|first1= P.J.|last2= Pilz |first2=B.|last3=Andersen|first3=K.E.|title=Patch testing with fragrances: results of a multi-center study of the European Environmental and Contact Dermatitis Research Group with 48 frequently used constituents of perfumes |journal=Contact Derm. |volume=33 |issue=5 |pages=333β42 |date=November 1995 |pmid=8565489 |doi= 10.1111/j.1600-0536.1995.tb02048.x|s2cid=44355890 |display-authors=etal}}</ref> [[Balsam of Peru]] was the main recommended marker for perfume allergy before 1977, it is still advised. The presence of Balsam of Peru in a cosmetic will be denoted by the [[International Nomenclature of Cosmetic Ingredients|INCI]] term ''Myroxylon pereirae''.<ref name="rook">{{citation | last1=Beck|first1=M. H. | last2=Wilkinson|first2= S. M. | chapter=26. Contact Dermatitis: Allergic |doi=10.1002/9781444317633.ch26 |isbn=978-1-4443-1763-3| title=Rook's Textbook of Dermatology | volume=2 | edition=8th | year=2010 | publisher=Wiley | page=26.40| s2cid=204093054 }}</ref><ref name="google3" /> In some instances, Balsam of Peru is listed on the ingredient label of a product by one of its [[Balsam of Peru#Alternate names|various names]], but it may not be required to be listed by its name by mandatory labeling conventions (in fragrances, for example, it may simply be covered by an ingredient listing of "fragrance").<ref name="google3">{{cite book |url=https://books.google.com/books?id=sSHIlWSOiroC&pg=PA556 |title=Contact Dermatitis |last1=Johansen|first1=Jeanne Duus |last2=Frosch|first2= Peter J. |last3=Lepoittevin|first3= Jean-Pierre |publisher=Springer |date=2010 |access-date=March 13, 2014 |isbn=978-3-642-03827-3 |archive-date=August 5, 2020 |archive-url=https://web.archive.org/web/20200805102351/https://books.google.com/books?id=sSHIlWSOiroC&pg=PA556 |url-status=live }}</ref><ref name="google7">{{cite book |url=https://books.google.com/books?id=dQBAzfyCeQ8C&pg=PA735 |title=Fisher's Contact Dermatitis |last=Fisher|first= Alexander A. |publisher=PMPH-USA |date=2008 |isbn=978-1-55009-378-0 |access-date=2015-11-06 |archive-date=2020-08-05 |archive-url=https://web.archive.org/web/20200805101125/https://books.google.com/books?id=dQBAzfyCeQ8C&pg=PA735 |url-status=live }}</ref><ref>{{cite book |url=https://books.google.com/books?id=Ef_HllqkdqEC&pg=PT514 |title=Andrew's Diseases of the Skin: Clinical Dermatology |first1=William D. |last1=James |first2=Timothy |last2=Berger |first3=Dirk |last3=Elston |publisher=Elsevier Health Sciences |date=2011 |isbn=978-1-4377-3619-9 |access-date=2015-11-06 |archive-date=2018-05-17 |archive-url=https://web.archive.org/web/20180517041148/https://books.google.com/books?id=Ef_HllqkdqEC&pg=PT514 |url-status=live }}</ref><ref>{{cite book|url=https://books.google.com/books?id=ORpbQRdlCpoC&pg=PA1042|title=Dermatotoxicology|edition=Sixth|last1=Zhai|first1=Hongbo|last2=Maibach|first2=Howard I.|publisher=CRC Press|date=2004|access-date=March 13, 2014|isbn=978-0-203-42627-2|archive-date=August 5, 2020|archive-url=https://web.archive.org/web/20200805090117/https://books.google.com/books?id=ORpbQRdlCpoC&pg=PA1042|url-status=live}}</ref> === Animal testing === {{Main|Testing cosmetics on animals}} Due to ethical concerns around animal testing, some nations have required evidence for safety that may involve animal testing for cosmetics.<ref name="fda-animal">{{cite web |title=Animal Testing & Cosmetics |url=https://www.fda.gov/cosmetics/product-testing-cosmetics/animal-testing-cosmetics |archive-url=https://web.archive.org/web/20190912074041/https://www.fda.gov/cosmetics/product-testing-cosmetics/animal-testing-cosmetics |url-status=dead |archive-date=12 September 2019 |publisher=US Food and Drug Administration |access-date=5 May 2025 |date=4 March 2022}}</ref> Cosmetics manufacturers are encouraged to ensure safe products, having responsibility to establish the safety of individual ingredients and the final product before going to market.<ref name=fda-animal/> When animal testing is used by a company, a national regulatory agency, such as the US FDA, encourages minimal use of animals and humane methods, also supporting that scientifically valid alternative methods to whole-animal testing be used.<ref name=fda-animal/> As of 2019, an estimated 50β100 million animals were tested each year in locations such as the United States and China.<ref>{{Cite journal|last1=Kabene|first1=Stefane|last2=Baadel|first2=Said|date=2019-11-12|title=Bioethics: a look at animal testing in medicine and cosmetics in the UK|journal=Journal of Medical Ethics and History of Medicine|volume=12|page=15|doi=10.18502/jmehm.v12i15.1875|issn=2008-0387|pmc=7166243|pmid=32328228}}</ref> Such tests may have involved eye and skin irritants, [[phototoxicity]] (toxicity triggered by [[ultraviolet]] light), and [[mutagenicity]].<ref>{{Cite book|title=Animal Testing: Issues and Ethics|last=Watson|first=Stephanie|publisher= The Rosen Publishing Group|location=New York|year=2009|isbn=978-1-4358-5671-4}}</ref><ref>{{cite journal | doi = 10.1371/journal.pone.0024059 | pmid = 21915280 | title = Ethical and Scientific Considerations Regarding Animal Testing and Research | journal = PLOS ONE | volume = 6 | issue = 9 | pages = e24059 | year = 2011 | last1 = Ferdowsian | first1 = Hope R. | last2 = Beck | first2 = Nancy|pmc=3168484 | bibcode = 2011PLoSO...624059F | doi-access = free }}</ref> In 2018, California banned the sale of animal-tested cosmetics.<ref>{{Cite news|url=https://www.huffpost.com/entry/california-just-officially-banned-the-sale-of-animal-tested-cosmetics_n_5b913ac6e4b0cf7b003d5c09|title=California Just Officially Banned The Sale Of Animal-Tested Cosmetics|last=Hanson|first=Hilary|date=2018-09-29|work=Huffington Post|access-date=2019-05-17|language=en-AU|archive-date=2019-05-17|archive-url=https://web.archive.org/web/20190517160322/https://www.huffpost.com/entry/california-just-officially-banned-the-sale-of-animal-tested-cosmetics_n_5b913ac6e4b0cf7b003d5c09|url-status=live}}</ref> Cosmetics testing is banned in the Netherlands, India, Norway, Israel, New Zealand, Belgium, and the UK. In 2002, the European Union agreed to phase in a near-total ban on the sale of animal-tested cosmetics throughout the EU from 2009 and to ban all cosmetics-related animal testing.<ref>{{Cite web|url=https://ec.europa.eu/growth/sectors/cosmetics/animal-testing_en|title=Ban on Animal Testing β Growth β European Commission|website=Growth|language=en|access-date=2018-10-26|date=2016-07-05|archive-date=2018-10-26|archive-url=https://web.archive.org/web/20181026182953/http://ec.europa.eu/growth/sectors/cosmetics/animal-testing_en|url-status=live}}</ref> In December 2009, the European Parliament and Council passed [[EC Regulation 1223/2009 on cosmetics#Restrictions for hazardous ingredients and animal testing|EC Regulation 1223/2009 on cosmetics]], a bill to regulate the cosmetic industry in the EU.<ref name="Regulation-2009">{{CELEX|02009R1223-20240424|text=Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (consolidated text)}}</ref> EC Regulation 1223/2009 took effect on July 11, 2013.<ref name="Regulation-2009" /> In March 2013, the EU banned the import and sale of cosmetics containing ingredients tested on animals.<ref>{{Cite news|url=https://www.nytimes.com/2013/03/11/business/global/eu-to-ban-cosmetics-with-animal-tested-ingredients.html|title=E.U. Bans Cosmetics With Animal-Tested Ingredients|last=Kanter|first=James|date=2013-03-11|work=The New York Times|access-date=2019-05-17|language=en-US|issn=0362-4331|archive-date=2019-05-09|archive-url=https://web.archive.org/web/20190509182353/https://www.nytimes.com/2013/03/11/business/global/eu-to-ban-cosmetics-with-animal-tested-ingredients.html|url-status=live}}</ref> China required animal testing on cosmetic products until 2014, when they waived animal testing requirements for domestically produced products.<ref>{{Cite web|url=https://www.bloomberg.com/news/articles/2018-01-16/ending-china-animal-tests-is-salve-for-big-beauty-quicktake-q-a|title=Here's How China Is Moving Away From Animal Testing|date=16 January 2018|website=www.bloomberg.com|access-date=2019-05-13|archive-date=2019-05-17|archive-url=https://web.archive.org/web/20190517160333/https://www.bloomberg.com/news/articles/2018-01-16/ending-china-animal-tests-is-salve-for-big-beauty-quicktake-q-a|url-status=live}}</ref> In 2019, China approved nine non-animal testing methods, and in 2020 laws making animal testing compulsory were lifted.<ref>{{Cite web|url=https://www.vogue.co.uk/article/china-lifting-animal-testing-laws|title=China Will No Longer Require Animal Testing On Cosmetic Products|last=Morosini|first=Daniela|website=British Vogue|date=10 April 2019|access-date=2019-05-13|archive-date=2019-05-13|archive-url=https://web.archive.org/web/20190513201237/https://www.vogue.co.uk/article/china-lifting-animal-testing-laws|url-status=live}}</ref> In June 2017, legislation was proposed in Australia to end animal testing in the cosmetics industry.<ref>{{Cite web|url=https://phys.org/news/2019-03-australia-animal-laws-good-dont.html|title=Australia's animal testing laws are a good start, but don't go far enough|website=phys.org|language=en-us|access-date=2019-05-17|archive-date=2019-05-17|archive-url=https://web.archive.org/web/20190517160311/https://phys.org/news/2019-03-australia-animal-laws-good-dont.html|url-status=live}}</ref> In March 2019, the [[Australian Senate]] passed a bill that banned the use of data from animal testing in the cosmetic industry since July 1, 2020.<ref>{{Cite web|url=https://www.smh.com.au/environment/sustainability/australia-bans-use-of-data-from-animal-tests-in-cosmetics-20190227-p510jo.html|title=Australia bans use of data from animal tests in cosmetics|last=Jacobs|first=Steve|date=2019-03-16|website=The Sydney Morning Herald|language=en|access-date=2019-05-17|archive-date=2019-05-17|archive-url=https://web.archive.org/web/20190517160311/https://www.smh.com.au/environment/sustainability/australia-bans-use-of-data-from-animal-tests-in-cosmetics-20190227-p510jo.html|url-status=live}}</ref>
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