REGULATIONS 81


Microbead-Free Waters Act of 2015 The Microbead-Free Waters Act of 2015 prohibits the manufacture and sale of rinse- off products containing plastic microbeads. The timeline set out in the act is to prohibit the manufacture of cosmetic products containing plastic microbeads by 1 July 2017, and their sale by 1 July 2018. For rinse-off cosmetics which are non-prescription drugs the timeline is one year later, manufacture must have ceased by 1 July 2018 and they must be off the market by 1 July 2019. The Microbead-Free Waters Act of 2015 defines plastic microbeads as “any solid plastic particle that is less than five millimetres in size and is intended to be used to exfoliate or cleanse the human body” and they include toothpaste as a rinse-off cosmetic.


Antibacterial soap Antibacterial personal care products such as antibacterial soaps, antibacterial hand washes and antibacterial body washes are considered to be over the counter (OTC) drug products. As part of a review of over the counter antiseptic washes the Food and Drug Administration has ruled that consumer antiseptic washes containing the following actives are not generally recognised as safe and effective (GRAS/GRAE) and are therefore misbranded: cloflucarban; fluorosalan; hexachlorophene; hexylresorcinol; iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate); iodine complex (phosphate ester of alkylaryloxy polyethylene glycol); nonylphenoxypoly (ethyleneoxy) ethanoliodine; poloxamer-iodine complex; povidone-iodine 5 to 10 percent; undecoylium chloride iodine complex; methylbenzethonium chloride; phenol (greater than 1.5 per cent); phenol (less than 1.5 per cent); secondary amyltricresols; sodium oxychlorosene; tribromsalan; triclocarban; triclosan; triple dye.14


The


ruling is effective from 6 September 2017. The ruling does not apply to leave-on products such as hand sanitizers. On 24 March 2017 the Food and Drug Administration deferred making a decision on the active ingredients benzalkonium chloride, benzethonium chloride, and chloroxylenol for a further year.15


California Safe Cosmetics Act In 2005 the State of California enacted the California Safe Cosmetics Act. The Act requires companies to report to the State of California any cosmetic products which contain ingredients known or suspected to cause cancer, birth defects or reproductive harm.16


The Act does not prohibit the sale


of these products. Companies are required to submit information about their product to the California Safe Cosmetics Programme if they have annual sales of


April 2018 Conclusion


This article has been written as a guide to the regulatory requirements for placing a cosmetic product on the market in the


Exporting to the US Cosmetic products exported to the US must comply with all the requirements which apply to cosmetic products manufactured within the US. They are subject to inspection and possibly sampling by US Customs and Border Protection at the point of entry to the US. Cosmetic products which appear to be adulterated or misbranded may be refused entry. Shipments found not to comply with US laws and regulations must be brought into compliance, destroyed or re-exported. Not all cosmetic products are examined at the time of entry to the US but still must be compliant with US laws and regulations.


cosmetic products of one million dollars or more and have sold cosmetic products in California on or after 1 January 2007. The California Department of Public Health has compiled a list of ingredients to help with reporting.17


The list includes Cocamide


DEA, coffee, 1,4-Dioxane, ethylene oxide, aloe vera whole leaf extract and non- colourised whole leaf extract, carbon black , formaldehyde, and titanium dioxide.


Cosmetic Ingredient Review (CIR) The Cosmetic Ingredient Review (CIR) reviews the safety of ingredients used in cosmetic products and is funded by the Personal Care Products Council. The Cosmetic Ingredient Review is independent of both the Personal Care Products Council and the cosmetics industry. The expert panel meets four times a year to consider the safety of cosmetic ingredients. Their opinions can be found on the Personal Care Products Council website.


United States of America. It has looked at the requirements of the Federal Food, Drug and Cosmetic Act, The Fair Packaging and Labeling Act, what makes a product adulterated or misbranded, colour additives, coal-tar hair dyes, plastic microbeads and sunscreens. More information on how cosmetic products and over the counter drugs are regulated can be found on the Food and Drug Administration website.18


PC


References References in brackets e.g. (21CFR 700.11) refer to United States Code of Federal Regulations 1 FD&C Act sec. 201(i) 2 https://www.fda.gov/downloads/ Cosmetics/Labeling/UCM391202.pdf


3 FD&C Act (21 CFR 331a) 4 Section 601 of FD&C Act (21USC 361) 5 Section 602 of FD&C Act (21USC 362) 6 Guidance for Industry Safety of Nanomaterials in Cosmetic Products


7 FD&C Act, 721 8 FD&C Act, 601(e) 9 FD&C Act, 601(a) 10 https://www.fda.gov/Cosmetics/ GuidanceRegulation/GuidanceDocuments/ ucm353046.htm


11 21 CFR 352.20 12 21 CFR 352.76 13 Non Prescription Sunscreen Drug Products – Safety and Effectiveness Data Guidance for Industry


14 Federal Register / Vol. 81, No. 172 / Tuesday, September 6, 2016/Rules and Regulations


15 Consumer Antiseptic Wash Final Rule Questions and Answers Guidance for Industry (Small Entity Compliance Guide).


16 https://safecosmetics.cdph.ca.gov/search/ faq-safe-cosmetics-program.aspx#1


17 https://www.cdph.ca.gov/Programs/CCDPHP /DEODC/OHB/CSCP/Pages/CSCP.aspx#


18 https://www.fda.gov/Cosmetics/ GuidanceRegulation/


PERSONAL CARE EUROPE


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