Legislation

Europeedit

In the European Union, the manufacture, labelling, and supply of cosmetics and personal care products are regulated by Regulation EC 1223/2009. 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 REACH, GMP, hazardous substances, etc.

In the European Union, the circulation of cosmetic products and their safety has been a subject of legislation since 1976. One of the newest improvement of the regulation concerning cosmetic industry is a result of the ban 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.

Cosmetic regulations in Europe are often updated to follow the trends of innovations and new technologies while ensuring product safety. For instance, all annexes of the Regulation 1223/2009 were aimed to address potential risks to human health. Under the EU cosmetic regulation, manufacturers, retailers, and importers of cosmetics in Europe will be designated as "Responsible Person". This new status implies that the responsible person has the legal liability to ensure that the cosmetics and brands they manufacture or sell comply with the current cosmetic regulations and norms. The responsible person is also responsible of 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 Statesedit

In 1938, the U.S. passed the 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. The FDA joined with 13 other federal agencies in forming the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) in 1997, which is an attempt to ban animal testing and find other methods to test cosmetic products.

The current law on cosmetics in the USA do not require cosmetic products and ingredients to have FDA approval before going on the market except from color additives. The Cosmetic Safety Enhancement Act was introduced in December 2019 by Representative Frank Pallone.

Braziledit

ANVISA (Agência Nacional de Vigilância Sanitária, Brazilian Health Surveillance Agency) is the regulatory body responsible for cosmetic legislation and 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 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 economic zone.

Internationaledit

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.

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