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INCI Names (International Nomenclature of Cosmetic Ingredients) are systematic names internationally recognized for identifying ingredients used in personal care products. They are approved by the International Nomenclature Committee (INC) and published by the Personal Care Products Council (PCPC) in the "International Cosmetic Ingredient Dictionary and Handbook."
According to China's Regulations on the Management of Cosmetic Registration and Filing Information, when registering cosmetic products, the names of all ingredients, including their standardized Chinese names, INCI names, or English names, should be provided.
When registering new cosmetic ingredients, the INCI name and its ID number are required. For ingredients already included in the "International Cosmetic Ingredient Dictionary and Handbook," their INCI English names and corresponding ID numbers should be specified. For ingredients not yet included, the corresponding English names should be provided.
When applying for an INCI name, applicants should collect relevant information based on the type of ingredient and submit the application on the PCPC website. The application process takes approximately 3-6 months.
According to the U.S. Federal Food, Drug, and Cosmetic Act (FD&C), cosmetics are defined as articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance, through methods such as rubbing, spraying, or other similar applications. However, it's important to note that soap is not considered a cosmetic. Oral hygiene products, on the other hand, are considered cosmetics in the United States, but certain products like anti-cavity toothpaste fall under OTC (Over-the-Counter) drugs.
Modernization of Cosmetics Regulation Act (MoCRA) 2022, which includes the following provisions:
(1) Mandatory registration of manufacturing facilities and products, with requirements to update the information every two years for facilities and annually for products.
(2) Each ingredient in cosmetics should have supporting safety data, and if there is insufficient evidence of ingredient safety, it is considered adulterated.
(3) Detailed provisions for adverse event reporting, requiring records and specific timeframes for reporting serious adverse events to the FDA within 15 working days. The labels should include a U.S. address and contact information for consumer reporting of adverse events.
(4) MoCRA grants the FDA the authority to order a mandatory recall of cosmetic products in cases where the use or exposure to the product can cause serious adverse health consequences or death, and the responsible party refuses a voluntary recall.
(5) Fragrance allergen labeling requirements, and within 18 months of MoCRA's publication, proposed regulations for fragrance allergens should be issued.
(6) Within three years, Good Manufacturing Practice (GMP) regulations for cosmetics should be promulgated; within one year, standard testing methods for asbestos in talc-containing products should be published; within three years, safety assessments of per- and polyfluoroalkyl substances (PFAS) in cosmetics should be completed and the results made public.
(7) Animal testing should be phased out unless required for specific situations.
Federal Food, Drug, and Cosmetic Act (FD&C): The FD&C Act addresses several aspects of cosmetics, including handling of adulterated cosmetics and misbranded labeling, detailed requirements for cosmetic packaging and labeling, specific provisions for certain cosmetic ingredients, voluntary registration by cosmetic manufacturers, voluntary ingredient declaration, and safety warnings for certain cosmetics containing specific ingredients.
In addition to these important regulations, the U.S. cosmetic regulatory landscape also involves multiple federal regulations at the national level, such as the Fair Packaging and Labeling Act (FPLA) and the National Organic Program (NOP). Furthermore, California has implemented the Safe Drinking Water and Toxic Enforcement Act, commonly known as Proposition 65. Additionally, 19 states, including California, have adopted state-level regulations such as the Model Toxics in Packaging Act published by the Toxics in Packaging Clearinghouse.
Substances or preparations intended to be placed in contact with the external parts of the human body (epidermis, hair, nails, lips, and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odors, excluding substances or preparations intended to be ingested, inhaled, injected or implanted into the human body.
In the process of placing cosmetics on the EU market, it is necessary to designate a responsible person and display it prominently on the label. The responsible person must be a legal entity or natural person established within the EU, and it is generally assumed that the responsible person for cosmetics is the manufacturer, importer, or distributor of cosmetics. The responsible person can also be a third party or natural person if authorized in writing.
The main legislation for cosmetics in Europe is Regulation (EC) No 1223/2009 of the European Parliament and of the Council, which was fully implemented on July 11, 2013, and applies in all 27 EU member states. The text of the regulation can be viewed at the following link:
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32009R1223&from=EN
Before placing cosmetics on the EU market, the cosmetics responsible person must conduct a safety assessment of the cosmetic products for sale and register the products through the European Cosmetics Products Notification Portal (CPNP). The notification information includes the Product Information File (PIF), with the Cosmetic Product Safety Report (CPSR) being the most stringent requirement. The CPSR, written and signed by a toxicologist with European certification, is an important part of ensuring the safety of product use.
Animal testing of finished cosmetic products intended for the EU market is prohibited, and the use of animal test data to demonstrate the safety of ingredients for cosmetics production is also prohibited. Instead, alternative methods that have been validated and recognized by the EU and the Organisation for Economic Co-operation and Development (OECD) should be used for safety testing and assessment of finished cosmetic products and ingredients.
EU cosmetic regulations also have specific requirements for labeling and identification of cosmetics placed on the EU market. The texts, names, trademarks, images, numbers, or other indications used on the labels and advertisements of cosmetics entering the EU market must not imply characteristics or effects that are inconsistent with the actual claims.
The Association of Southeast Asian Nations (ASEAN), established in 1967, consists of 10 member countries: Malaysia, Thailand, Vietnam, Myanmar, Cambodia, Laos, Singapore, Indonesia, the Philippines & Brunei.
The definition of cosmetics in ASEAN is generally consistent with the definition of cosmetics in the EU. All ASEAN countries follow the ASEAN Cosmetic Directive (ACD), which is based on Regulation (EC) No 1223/2009/EC. Information on the ACD can be found on the ASEAN official website (https://asean.org）.
The ACD does not have specific provisions regarding animal testing of cosmetics. According to the ASEAN Guidelines for the Safety Evaluation of Cosmetics, there is no requirement for finished product testing to be conducted using animal toxicology. The ASEAN official website's cosmetics FAQ also does not explicitly prohibit animal testing.
In the ASEAN region, mutual recognition among member countries is not yet established, and cosmetics companies still need to complete separate notifications in each ASEAN country before they can be placed on the market. The basic information for product notification includes formulation, labeling, authorization letter, Good Manufacturing Practice (GMP), Free Sales Certificate, and the local company's business license. The company or person responsible for placing the cosmetics on the market in each ASEAN member country must be located in that country and must complete the product notification with the local regulatory authority. Furthermore, the product information file must be maintained and accessible to regulatory authorities.
The Canadian government regulates the cosmetics industry through the Cosmetic Program of Health Canada. The regulatory authority for cosmetics is derived from the Food and Drugs Act and the Cosmetic Regulations.
Cosmetics are defined as "any substance or mixture of substances manufactured, sold, represented for use in cleansing, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes." This definition also includes cosmetics used in professional beauty services and a wide range of institutional products (such as hand soaps in school restrooms).
The Cosmetic Program of Health Canada aims to protect the health of Canadians by minimizing the risks associated with the use of cosmetics in the Canadian market. The program establishes and communicates requirements for the production, labeling, distribution, and sale of cosmetics, and assesses compliance.
Similar to the United States, manufacturers are responsible for ensuring that their products comply with legal requirements before they are placed on the market. Cosmetic manufacturers or importers are responsible for demonstrating the safety of the intended use of cosmetics. The regulations are enforced by product safety officers within regional offices responsible for inspections, investigations, seizures, recalls, and prosecutions.
How is the "Period After Opening (PAO)" of cosmetics determined in the European Union?
Products with a shelf life exceeding 30 months usually require a symbol indicating the period after opening during which the product can be used without any adverse effects to the consumer ("PAO"). However, this requirement does not apply to single-use products, products with no risk of deterioration, or products in airtight packaging. The determination of PAO also takes into account the type of product and conditions of use. For example, cosmetics intended for sensitive areas (around the eyes, mucous membranes, damaged skin) and specific populations (children under 3 years old, elderly individuals, immunocompromised individuals) should have a shortened PAO. The PAO is indicated on the packaging (expressed in months and/or years).
What naming principle is used for the ingredient list on European Union cosmetic labels?
The ingredient list on cosmetic labels within the European Union does not need to be labeled in the national language or alphabet but is instead labeled using INCI names. This naming principle originated from the cosmetics industry in Europe and the United States and has been adopted by an increasing number of countries, including Canada, Australia, Singapore, and South Africa. The ingredient list on the label must be preceded by the term "INGREDIENTS."
Which ingredients are prohibited by the U.S. FDA from use in cosmetics?
Apart from color additives and a few prohibited ingredients, cosmetic manufacturers in the United States can use almost any raw material as cosmetic ingredients and sell the product without FDA approval. The Federal Food, Drug, and Cosmetic Act requires color additives used in cosmetics to undergo safety testing and be listed by the FDA for their intended use.
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