Editing Cosmetics (section)

== Legislation ==

=== Europe ===
In the European Union, the manufacture, labelling, and supply of cosmetics and personal care products are regulated by [[EC Regulation 1223/2009 on cosmetics|Regulation EC 1223/2009]].<ref name="Regulation-2009"/> It applies to all the countries of the EU as well as Iceland, Norway, and Switzerland. This regulation applies to single-person companies making or importing just one product as well as to large multinationals. Manufacturers and importers of cosmetic products must comply with the applicable regulations in order to sell their products in the EU. In this industry, it is common fall back on a suitably qualified person, such as an independent third party inspection and testing company, to verify the cosmetics' compliance with the requirements of applicable cosmetic regulations and other relevant legislation, including [[Registration, Evaluation, Authorisation and Restriction of Chemicals|REACH]], [[Good manufacturing practice|GMP]], [[Dangerous goods|hazardous substances]], etc.<ref>{{cite web|url=https://www.bis.gov.uk/policies/consumer-issues/product-safety/cosmetic-products-safety-regulations-2008-as-amended|title=Product safety for manufacturers|work=bis.gov.uk|access-date=2022-02-21|archive-date=2012-11-05|archive-url=https://web.archive.org/web/20121105052730/http://www.bis.gov.uk/policies/consumer-issues/product-safety/cosmetic-products-safety-regulations-2008-as-amended|url-status=live}}</ref><ref>{{cite web|url=https://cosmeticseurope.eu/cosmetics-industry/understanding-cosmetics-regulation/|title=The Single Market|work=cosmeticseurope|access-date=2021-07-01|archive-date=2021-06-05|archive-url=https://web.archive.org/web/20210605202506/https://cosmeticseurope.eu/cosmetics-industry/understanding-cosmetics-regulation/|url-status=live}}</ref>

In the European Union, the circulation of cosmetic products and their safety have been the subject of legislation since 1976. One of the newest improvements to the regulation concerning the cosmetic industry is the ban on [[animal testing]]. Testing cosmetic products on animals has been illegal in the European Union since September 2004, and testing the separate ingredients of such products on animals is also prohibited by law, since March 2009 for some endpoints and full since 2013.<ref>{{cite web|url=https://ec.europa.eu/consumers/sectors/cosmetics/animal-testing/index_en.htm|title=Regulatory context|access-date=2010-08-04|publisher=ec.europa.eu|archive-date=2010-07-20|archive-url=https://web.archive.org/web/20100720005200/http://ec.europa.eu/consumers/sectors/cosmetics/animal-testing/index_en.htm|url-status=live}}</ref>

Cosmetic regulations in Europe are often updated to follow the trends of innovations and new technologies while ensuring [[safety standards|product safety]]. For instance, all annexes of Regulation 1223/2009 were aimed at addressing potential risks to human [[health]].
Under the EU cosmetic regulation, manufacturers, retailers, and importers of cosmetics in Europe will be designated as "responsible persons.".<ref name="Regulation-2009"/> This new status implies that the responsible person has the [[legal liability]] to ensure that the cosmetics and [[brand]]s they manufacture or sell comply with the current cosmetic regulations and norms. The responsible person is also responsible for the documents contained in the Product Information File (PIF), a list of product information including data such as Cosmetic Product Safety Report, product description, [[GMP statement]], or product function.

=== United States ===
In 1938, the U.S. passed the [[Federal Food, Drug, and Cosmetic Act|Food, Drug, and Cosmetic Act]] authorizing the [[Food and Drug Administration]] (FDA) to oversee safety via legislation in the cosmetic industry and its aspects in the United States.<ref>{{cite web|url=https://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/default.htm|title=Federal Food, Drug, and Cosmetic Act (FD&C Act)|work=fda.gov|access-date=2019-12-16|archive-date=2017-03-18|archive-url=https://web.archive.org/web/20170318023122/https://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/default.htm|url-status=dead}}</ref><ref>{{cite web|url = https://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/ucm132818.htm|title = The 1938 Food, Drug, and Cosmetic Act|website = [[Food and Drug Administration]]|access-date = 22 April 2015|archive-date = 2 May 2015|archive-url = https://web.archive.org/web/20150502135903/http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/ucm132818.htm|url-status = dead}}</ref> The FDA joined with 13 other federal agencies in forming the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) in 1997, which was intended to ban animal testing and find other methods to test cosmetic products,<ref>{{cite web|title=Animal Testing & Cosmetics|website=[[Food and Drug Administration]]|url=https://www.fda.gov/cosmetics/scienceresearch/producttesting/ucm072268.htm|access-date=10 February 2017|archive-date=11 February 2017|archive-url=https://web.archive.org/web/20170211084328/http://www.fda.gov/cosmetics/scienceresearch/producttesting/ucm072268.htm|url-status=dead}}</ref> although regulations in 2022 permit animal testing as a method to ensure safe use for consumers.<ref name=fda-animal/>

The current law on cosmetics in the U.S. does not require cosmetic products and ingredients to have FDA approval before going on the market, except for color additives.<ref name=fda-reg/> The Cosmetic Safety Enhancement Act was introduced in December 2019.<ref name="PBS">{{cite web |title=Why your cosmetics don't have to be tested for safety |url=https://www.pbs.org/newshour/health/why-your-cosmetics-dont-have-to-be-tested-for-safety |website=PBS |language=en |date=16 December 2019 |access-date=19 August 2020 |archive-date=2 October 2020 |archive-url=https://web.archive.org/web/20201002162341/https://www.pbs.org/newshour/health/why-your-cosmetics-dont-have-to-be-tested-for-safety |url-status=live }}</ref>

=== Brazil ===

ANVISA (Agência Nacional de Vigilância Sanitária, ''Brazilian Health Surveillance Agency'') is the regulatory body responsible for cosmetic legislation and [[:wikt:directive|directives]] in the country. The rules apply to manufacturers, importers, and retailers of cosmetics in Brazil, and most of them have been harmonized so they can apply to the entire [[Mercosur]].

The current legislation restricts the use of certain substances, such as pyrogallol, [[formaldehyde]], or paraformaldehyde, and bans the use of others, such as lead [[acetate]] in cosmetic products. All restricted and forbidden substances and products are listed in the regulation RDC 16/11 and RDC 162, 09/11/01.

More recently, a new cosmetic [[Technical Regulation]] (RDC 15/2013) was set up to establish a list of authorized and restricted substances for cosmetic use, used in products such as [[Hair coloring|hair dyes]], nail hardeners, or used as product preservatives.

Most Brazilian regulations are optimized, harmonized, or adapted in order to be applicable and extended to the entire Mercosur [[Special economic zone|economic zone]].

=== International ===
The [[International Organization for Standardization]] (ISO) published new guidelines on the safe manufacturing of cosmetic products under a Good Manufacturing Practices (GMP) regime. Regulators in several countries and regions have adopted this standard, ISO 22716:2007, effectively replacing existing guidance and standards. 
ISO 22716 provides a comprehensive approach for a quality management system for those engaged in the manufacturing, packaging, testing, storage, and transportation of cosmetic end products. The standard deals with all aspects of the supply chain, from the early delivery of raw materials and components until the shipment of the final product to the consumer.

The standard is based on other quality management systems, ensuring smooth integration with such systems as ISO 9001 or the British Retail Consortium (BRC) standard for consumer products. Therefore, it combines the benefits of GMP, linking cosmetic product safety with overall business improvement tools that enable organisations to meet global consumer demand for cosmetic product safety certification.<ref>[https://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=36437 ISO 22716] {{Webarchive|url=https://web.archive.org/web/20161004180415/http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=36437 |date=2016-10-04 }} ISO Guidelines on Good Manufacturing Practices, Retrieved 09/27/2012</ref>

In July 2012, since microbial contamination is one of the greatest concerns regarding the quality of cosmetic products, the ISO introduced a new standard for evaluating the antimicrobial protection of a cosmetic product by preservation efficacy testing and microbiological risk assessment.