Global Cosmetic Compliances & Guidelines; Who Regulates & What Regulates?
Canada:
The Canadian government regulates the cosmetics industry through Health Canada’s Cosmetics Program. Canadian regulations relating to Cosmetics (C.R.C, c.869) form part of Canada’s Food & Drugs Act. All cosmetics sold in Canada must meet the requirements of the Food and Drugs Act and the Cosmetic Regulations.
Health Canada: Cosmetic Ingredient Hotlist
European Union:
The EU regulation on cosmetic products ensure uniformity in the implementation of the rules governing the cosmetics industry across all EU member states. It strengthens the safety of cosmetic products and streamlines the framework for all operators in the sector. The regulation simplifies procedures to the extent that the internal market of cosmetic products is now a reality.
Apart from the main regulatory framework for finished cosmetic products, additional requirements covered by other EU legislation might apply. Some of them are listed below.
Chemicals website of the European Commission including information on restrictions on the marketing and use of certain dangerous substances and preparations
Climate website of the European Commission regarding ozone-depleting substances contained in aerosol products
Pressure and gas website of the European Commission relating to aerosol dispensers
Legal metrology and pre-packaging website of the European Commission with information on nominal quantities and nominal capacities permitted for certain prepackaged products
Environment website of the European Commission on packaging and packaging waste
China:
In China, cosmetics and cosmetic ingredients are regulated by the following laws:
- Regulations concerning the hygiene supervision over cosmetics(1990);
- Detailed Rules for the Implementation of the Regulation on the Hygiene Supervision over Cosmetics(2005);
- Hygienic Standard for Cosmetics(2007)
- The Measures for the Administration of Hygiene License for Cosmetics (revised in 2010);
- Guideline for Risk Evaluation of Substances with Possibility of Safety Risk in Cosmetics(2010);
- Standard Chinese Names of International Cosmetics Ingredients Inventory (2010);
- Cosmetics Technical Requirement Standard(2011);
- Guidelines for the Registration and Evaluation of New Cosmetic Ingredient(2011);
- AQSIQ Order No. 143 of 2011 - The Administrative Measures on the Inspection, Quarantine and Supervision of Chinese Imported & Exported Cosmetics (2011)
For finished cosmetics, companies who plan to place cosmetics on Chinese market must apply for and obtain hygiene license or record-keeping certificate from the China Food & Drug Administration(CFDA). Foreign companies shall appoint a Chinese responsible agent to deal with registration and obtain such certificate. Manufacturers shall also register a new cosmetic ingredient prior to using it for cosmetics production.
Korea:
The Ministry of Food and Drug Safety (MFDS) is also responsible for the Cosmetics and Personal care sector under a number of Directives. In this regard they take control of the risk profile of the products, hazardous substance criteria, label information, test methods, and GMP qualification of manufacturing sites. Product launches need to be registered and manufacturers need to take notice of the Cosmetic Ingredient Database for forbidden substances. For substances that are not listed in this database additional testing is required, for example toxicology testing, mutagenicity testing, etc. All products are registered and product performance has to be reported to the MFDS annually. The Korean MFDS Cosmetics GMP is benchmarked against ISO 22716 and while adherence to it is not currently mandatory across all products, it is expected to be in the near future to support the recognition of the standard of Korean manufactured products within other markets.
USA:
The FDA regulates cosmetics under the authority of these laws Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). The United States requires that any cosmetics comply with the ‘Cosmetics Safety Amendments Act of 2012’. This legislation was introduced to strengthen and modernise the previous Federal Food, Drug and Cosmetic Act (FD&C Act, March 2005) and the Fair Packaging and Labelling Act (FPLA, August 1992) giving the Food & Drug Administration a greater role in assessing the safety of personal care products. Cosmetics - Food and Drug administration
India:
Central drug standard control organization (CDSCO) which is headed by the Drugs Controller General of India is the the central authority for discharging regulatory functions. It is a statutory authority established under the Drugs and Cosmetics Act 1940 and the Drugs and Cosmetics Rules, 1945. The primary goal of CDSCO is to ensure the safety, efficiency and quality of drugs, cosmetics and medical devices. Every state also consists of a state level authority known as the SDCA that is the State Drug Control Authority which is responsible for implementation of the regulations under the Drugs and Cosmetics Act, 1940.
The cosmetic products in India are also regulated by the Bureau of Indian Standards (BIS) which lays down standards for cosmetics for the products laid down under Schedule ‘S’ of the Drugs and Cosmetics Act Rules 1945 which comprises of a list of 30 different types of cosmetics like skin powders, creams, pastes and tooth powders, hair oil, soaps, shaving creams etc. Any cosmetics in a finished product form which is included under Schedule-S of D & C Rules should conform to the Indian Standards specifications laid down by BIS from time to time.
Japan:
Japanese cosmetics are regulated under Pharmaceutical and Medical Devices Law (PMDL, formerly Pharmaceutical Affairs Law) supported by a series of subsidiary rules, standards and guidance documents issued by the competent authority, Ministry of Health, Labour and Welfare (MHLW). Japan legally classifies cosmetics (in the broad sense of beauty products) into two categories: cosmetics and quasi drugs. The law defines cosmetics as “articles with mild action on the human body, which are intended to be applied to the human body through rubbing, sprinkling or other method, aiming to clean, beautify and increase the attractiveness, alter the appearance or to keep the skin or hair in good condition.”
Under this law, soaps are classified as cosmetics; other classifications are: “perfume and eau de cologne” including fragrance; “makeup cosmetics” such as foundation creams, lipsticks and eye makeup; “skin care cosmetics,” i.e., facial cream, skin lotion, skin milk and cleansing cream; “hair care products” including hair dye, shampoo and hair treatments; and “special-purpose cosmetics” such as sunscreen.
Importers of cosmetics into Japan assume all quality assurance and product liabilities and they must be ready to take full responsibility for imported cosmetics through regulation analysis and safety testing.
Brazil:
Brazil’s cosmetic market is flourishing, showing no signs of slowdown even in the economic fluctuations. In Brazil, cosmetics in various segments such as organic, skincare, haircare, etc. are gaining popularity among users, and their market extent is increasing day by day. It is the responsibility of National Agency of Health Surveillance (ANVISA), functioning under the Ministry of Health, to regulate and approve the manufacture, import and trade of cosmetics in Brazil.
Be it low-risk products such as simple shampoos or high-risk products like baby products with special claims, it is mandatory to inform the Health Authority before being marketed in the country. To do so, manufactures and importers must obtain approval from ANVISA either through registration or notification. The success of registration or notification, however, highly depends on how compliant the manufacturer is when implementing the following 4 key aspects.
- Product Classification
- Ingredients Listing
- Product Dossier
- Notification / Registration Validity
South Africa:
The South African Bureau of Standards (SABS) together with the CTFA (SA) and industry has developed a range of standards. Cosmetic products are not subject to registration. There is an in-market control system rather than a pre-market control system. However, all formulas containing ethyl alcohol and manufactured in South Africa must be registered with the Department of Customs and Excise for duty rebate on alcohol usage.
Australia:
Australia legally classifies beauty products into two categories: cosmetics and therapeutic goods. The regulations governing each category differ greatly. The difference between therapeutic goods and cosmetics is not always clear. The main factors in determining whether a product is a cosmetic or a therapeutic good are:
- its ingredients
- the route of administration
- if therapeutic claims are made on its label, or in advertising
Cosmetics in Australia are classified as industrial chemicals. “National Industrial Chemicals Notification and Assessment Scheme (NICNAS)” is responsible for managing industrial chemicals (cosmetics) and Australian Competition and Consumer Commission (ACCC) regulates the product safety and cosmetic labelling standards.
Therapeutic goods are managed by Therapeutic Goods Administration. TGA is responsible for formulating and implementing the regulations concerning registration of sponsors, advertising, labelling and manufacturing of therapeutic goods.
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