REGISTRATION OF COSMETICS IN THE USA - Global Regulatory Partners, Inc.

REGISTRATION OF COSMETICS IN THE USA

Global Regulatory Partners, Inc FDA COSMETIC REGULATIONS Cosmetics marketed in the United States, whether manufactured domestically or imported must comply with the following regulations: Federal Food, Drug, and Cosmetic Act (FD&C Act), Fair Packaging and Labeling Act External Link Disclaimer (FP&L Act). DEFINITION The US FDA defines a cosmetic is a product, (except soap), intend to be applied to the human body for cleansing, beautifying, promoting attractiveness or altering the appearance. 2

Global Regulatory Partners, Inc HOW DOES THE FDA CLASSIFY COSMETICS? Classification of your Product Is the product intended for uses such as cleansing the human body, making a person more attractive, or changing a person’s appearance? Is the product composed mainly of the “alkali salts of fatty acids,” that is, the material? It is a cosmetic It is a soap Is the product intended to affect the way a person’s body works, or to treat or prevent disease? It is a Drug Is it intended to affect the structure or any function of the body of man and does not achieve its primary intended purpose through chemical action within or on the body of man? It is a Medical device If a product has both characteristic of a cosmetic and drug such as an acne treatment or dandruff shampoo it must be registered satisfying both regulation requirements 3

Global Regulatory Partners, Inc HOW TO REGISTER A COSMETIC IN THE USA? The Law does not require that cosmetic products or ingredients (with the exception of color additives) to have FDA approval prior to entering the market. It is the firm’s responsibility to ensure that its cosmetic products and ingredients are safe and properly labeled, in full compliance with the law. The FDA highly recommends voluntary registration of their cosmetics through the Voluntary Cosmetic Registration Program (VCRP). The VCRP applies only to cosmetic products being sold to consumers in the United States. It does not apply to cosmetic products for professional use only, such as products used in beauty salons, spas, or skin care clinics. VCRP COSMETIC REGISTRATION PROCESS Step 1:Check the list of ingredients (ensure none of ingredients are listed on the forbidden list.) Step 2: Check the content of Labeling and packaging requirements Step 3: Register Establishment Step 4: File the Cosmetic ingredient Registration of Cosmetics in the USA www.globalregulatorypartners.com 4

Global Regulatory Partners, Inc 1. Check the List of Ingredients The following ingredients are prohibited in cosmetics in the United States: Halogenate Salicylanilides Mercury compounds Chlorofluorocarbon Propellants Methylene chloride Hexachlorophene (Nabac) Bithionol Prohibited Cattle Material Vinyl chloride Zirconium- containing complexes 2. Check Content of Labeling & Packaging Labeling requirements: FDA regulates cosmetic labeling under the authority of both the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). The FDA does not have the resources or authority under the law for pre-market approval of cosmetic product labeling. It is the manufacturer’s and/or distributor’s responsibility to ensure that products are labeled properly. Failure to comply with labeling requirements may result in a misbranded product. All labeling information must be in English. The only exception to this rule is for products distributed solely in a U.S. territory where a different language is predominant, such as Puerto Rico. Registration of Cosmetics in the USA www.globalregulatorypartners.com 5

Requirements for Principal display and Information Panel Table 1: Information requirements for both the principal display panel and information panel on cosmetics. Requirements for Principal Display Panel Identity statement Net quantity of contents Statement indicating the nature and use of the product, by means of either the common or usual name, a descriptive name, a fanciful name understood by the public, or an illustration [21 CFR 701.11]. An accurate statement of the net quantity of contents, in terms of weight, measure, numerical count or a combination of numerical count and weight or measure. [21 CFR 701.13]. Required Information on side Panel Name and place of business. Distributor Statement Regulation Regulation This may be the manufacturer, packer, or distributor. This includes the street address, city, state, and ZIP Code. You may omit the street address if it is listed in a current phone directory or city directory [21 CFR 701.12(a)]. If the name and address are not those of the manufacturer, the label must say “Manufactured for.” or “Distributed by.,” or similar wording expressing the facts [21 CFR 701.12(c)]. 6

Global Regulatory Partners, Inc Required Information on side Panel Material facts Warning and caution statements Ingredients Failure to reveal material facts is one form of misleading labeling and therefore makes a product misbranded An example is directions for safe use, if a product could be unsafe if used incorrectly. The FD&C Act and related regulations specify warning and caution statements related to specific products Cosmetics that may be hazardous to consumers must bear appropriate label warnings If the product is sold on a retail basis to consumers, even it is labeled “For professional use only” or words to that effect, the ingredients must appear on an information panel, in descending order of predominance If the product is also a drug, its labeling must comply with the regulations for both OTC drug and cosmetic ingredient labeling Regulation [21 CFR 1.21]. [21 CFR part 700]. [21 CFR 740.1]. [21 CFR 701.3]. Packaging Requirements The FDA requires all liquid oral hygiene products such as mouthwashes and all cosmetic vaginal products to be packaged in tamper-resistant packages when sold at retail. A package is considered tamper resistant if it has an indicator or barrier to entry (e.g., shrink or tape seal) which, if breached or missing, alerts a consumer that tampering has occurred. FDA Testing Requirements Testing of Cosmetics is not required by the US FDA. 7

Global Regulatory Partners, Inc 3. Register Establishment with FDA To register an establishment with the FDA one must first request a new account from the FDA. Once the account is created the owners or operators of cosmetic manufacturing or packing facilities can complete (FDA Form 2511) and upload it onto VCRP platform. It is important to note that distributors cannot register an establishment. To complete Form 2511 the following information is required: Parent Company name Address Owner or Operator of the Facility Other businesses Trade names Establishment Authorized individual 4. File Cosmetic Product Ingredient Statement Once Form 2511 is completed and submitted one may continue to complete File their Cosmetic Product Ingredient using Form 2512. To file a Cosmetic formulation with the FDA one must complete Form 2512 - the Cosmetic Ingredient Statement (CPIS). To complete Form 2512 the following information is required: Labeler information Manufacturer Information Packer information Indicate whether filed product is already distributed in the USA Product information » Select product category » Product code » Brand name/ specific product name » Product website » Upload label images Ingredient Information » Can enter either CAS/ VCRP code number or common, usual, chemical name. Authorized individual name 8

Global Regulatory Partners, Inc REFERENCES: Federal Food, Drug, and Cosmetic Act (FD&C Act) FDA. (n.d.). Retrieved May 4, 2020, from ct Fair Packaging and Labeling Act: Regulations Under Section . (n.d.). Retrieved May 4, 2020, from g-act-regulations-0 Summary of Cosmetics Labeling Requirements FDA. (n.d.). Retrieved May 4, 2020, from egulations/summary-cosmetics-labelingrequirements 9

Global Regulatory Partners, Inc ABOUT GLOBAL REGULATORY PARTNERS, INC Global Regulatory Partners Inc, (GRP) provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. As a qualified and licensed legal representative with offices in USA, China, Japan, Brazil, Mexico and Argentina, the company can represent life science companies in those countries and help them register their products in compliance with local regulations and in record time. For additional information, please contact us at info@globalregulatorypartners.com Corporate Office Address: 400 Fifth Avenue, Suite #115, Waltham, MA 02451 Email: info@globalregulatorypartners.com Website: www.globalregulatorypartners.com Telephone: 781.672.4200 Brazil Mexico Rafael Marino Street, NETO 600 Karaiba Garden UBERLANDIA – 38411-186 Minas Gerais (MG) Telephone: ( 55) 34-3235-1971 Lake Alberto 442 – 5th floor Tower A – Office 509 Col. Anahuac 1st Section Delegation Miguel Hidalgo, C.P. 11320 Telephone: ( 52) 55 7312 4169 Japan China Ark Mori Building, Suite 50, 12/F 1-12-32 Akasaka Minato-K Tokyo, 107-6012 Telephone : ( 81)-3-4360-9287 21st Centry Tower, Suite 6030, 6/F 210 Centry Avenue, Pudong District Shanghai, 200120 Telephone: ( 86) 021-517-27278

Cosmetic Registration Program (VCRP). The VCRP applies only to cosmetic products being sold to consumers in the United States. It does not apply to cosmetic products for professional use only, such as products used in beauty salons, spas, or skin care clinics. VCRP COSMETIC REGISTRATION PROCESS Step 1:Check the list of ingredients (ensure