In the United States: “Under the law, cosmetic products and ingredients do not need FDA premarket approval.”The EU and other regulatory agencies around the world have more stringent regulations. The FDA does not have to approve or review cosmetics, or what goes in them, before they are sold to the consumers. The FDA only regulates against some colors that can be used in the cosmetics and hair dyes. The cosmetic companies do not have to report any injuries from the products; they also only have voluntary recalls of products.
There has been a marketing trend towards the sale of cosmetics lacking controversial ingredients, especially those derived from petroleum, sodium lauryl sulfate (SLS), and parabens. Numerous reports have raised concern over the safety of a few surfactants, including 2-butoxyethanol. In some individuals, SLS may cause a number of skin problems, including dermatitis.
Parabens can cause skin irritation and contact dermatitis in individuals with paraben allergies, a small percentage of the general population.Animal experiments have shown that parabens have a weak estrogenic activity, acting as xenoestrogens.
Perfumes are widely used in consumer products. Studies concluded from patch testing show fragrances contain some ingredients which may cause allergic reactions.
Balsam of Peru was the main recommended marker for perfume allergy before 1977, which is still advised. The presence of Balsam of Peru in a cosmetic will be denoted by the INCI term Myroxylon pereirae.In some instances, Balsam of Peru is listed on the ingredient label of a product by one of its 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”).
Some cosmetics companies have made pseudo-scientific claims about their products which are misleading or unsupported by scientific evidence.
Animal testing of Cosmetics
Cosmetics testing on animals is particularly controversial. Such tests involve general toxicity, eye and skin irritancy, phototoxicity (toxicity triggered by ultraviolet light), and mutagenicity.
Due to the controversy over the ethics of animal testing, alternatives to animal testing are in development, and some nations have chosen to legislate on animal testing with cosmetics. There are nearly 50 non-animal tests that have been validated for use, with many more in development, that may replace animal testing and are potentially more efficacious.Cosmetics testing is banned in the Netherlands, India, Norway, Israel, New Zealand, Belgium, and the UK, and in 2002, after 13 years of discussion, the European Union (EU) 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. Animal testing is regulated in EC Regulation 1223/2009 on cosmetics. France, which is home to the world’s largest cosmetics company, L’Oréal, has protested the proposed ban by lodging a case at the European Court of Justice in Luxembourg, asking that the ban be quashed. The ban is also opposed by the European Federation for Cosmetics Ingredients, which represents 70 companies in Switzerland, Belgium, France, Germany, and Italy.A plethora of cosmetic companies are cruelty free including: Bath and Body Works, Milani, Kat Von D, ELF, Too Faced Cosmetics, Lush, Physicians Formula, Urban Decay, Wet n Wild, Smashbox, and a variety of others.PETA has links on their website that users can sign encouraging makeup brands to become cruelty free.
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.
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.
All cosmetics which have been tested on animals are not permitted for import into India. Any cosmetics which has active component of Hexachlorophene, Lead or Arsenic compounds and mercury compounds are not allowed to be manufactured and imported in India.All cosmetics has to be registered in India with government.
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.
International Regulations for safe manufacturing of Cosmetics
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.