Kirk-Othmer Chemical Technology of Cosmetics

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• Publisher: Wiley
• Year: 2012
• Print ISBN: 9781118406922
• eBook ISBN: 9781118518908
• Edition: 1
• Topic: Physical Sciences
• Subtopic: Industrial & Technical Chemistry

Educating professionals and students about the chemistry, formulation technology, and related regulatory aspects of cosmetics and perfume

Cosmetics and perfume comprise a multibillion-dollar global industry. Kirk-Othmer Chemical Technology of Cosmetics provides authoritative information on the substances and processes involved, including key product groups, ingredients, formulation technology, packaging, and regulatory topics in twenty-two articles.

This resource makes sense of a vast group of consumer products designed to improve the health, cleanliness, and physical appearance of the human exterior. It identifies natural and synthetic ingredients and gives details on formulation of the product so that the cosmetic is safe, easy to use, and performs as described. Particular attention is paid to the technologies that have been developed to produce them, including emulsification, stick technology, powder blending, and aerosol technology. Packaging is also addressed, as it must be attractive to the consumer, be environmentally friendly, and keep the product safe as well. Regulatory information reinforces the safety aspect.

Based on Wiley's renowned Kirk-Othmer Encyclopedia of Chemical Technology, this book presents new and carefully updated articles, and features the same breadth and quality of coverage and clarity of presentation found in the original. This comprehensive guide is a valuable resource for chemists, R&D professionals, dermatologists, patent attorneys, regulatory agencies, and other professionals in the field of personal care products. It is also a must-have reference for students who plan to enter the field.

Part I

Products

1

Cosmetics

Martin M. Rieger

M & A Rieger, Associates

1.1 Introduction

Cosmetics are products created by the cosmetic industry and marketed directly to consumers. The cosmetic industry is dominated by manufacturers of finished products, but also includes manufacturers who sell products to distributors as well as suppliers of raw and packaging materials. Cosmetics represent a large group of consumer products designed to improve the health, cleanliness, and physical appearance of the human exterior and to protect a body part against damage from the environment. Cosmetics are promoted to the public and are available without prescription.

The difference between a cosmetic and a drug is often confusing. In the United States, the inclusion of a drug constituent, as defined by the Food and Drug Administration (FDA), in a cosmetic product may make the product a drug; whenever there is a claim for pharmacological activity of one of a product's constituents, the product is a drug. Some products are identified as quasi or over-the-counter (OTC) drugs according to each country's regulations. The composition, claim structure, and distribution of OTC products may be more tightly regulated than those of pharmacologically inactive cosmetics. The difference between an ordinary cosmetic and a quasi or OTC drug may not be readily apparent; it is based on statutory regulations. Certain types of products, such as hair-growth products and skin rejuvenators, are not cosmetics, and OTC claims for hair growth or skin rejuvenation are not allowed in the United States. These products have been referred to as cosmeceuticals.

Cosmetics, regardless of form, can be grouped by product use into the following seven categories: (1) skin care and maintenance, including products that soften (emollients and lubricants), hydrate (moisturizers), tone (astringents), protect (sunscreens), etc., and repair (antichapping, antiwrinkling, antiacne agents); (2) cleansing, including soap, bath preparations, shampoos, and dentrifices; (3) odor improvement by use of fragrance, deodorants, and antiperspirants; (4) hair removal, aided by shaving preparations, and depilatories; (5) hair care and maintenance, including waving, straightening, antidandruff, styling and setting, conditioning, and coloring products; (6) care and maintenance of mucous membranes by use of mouthwashes, intimate care products, and lip antichapping products; and (7) decorative cosmetics, used to beautify eyes, lips, skin, and nails.

Reference 1 gives formulations for products in all of the categories listed above.

1.2 History

Cosmetic preparations and usage are rooted in antiquity, when suspensions of natural pigments in lipids were evidently used to enhance appearance, and fragrant plant concoctions were widely traded. The use of cosmetics for adornment is recorded in biblical writings, and the use of soap, probably a hydrolysate of animal lipids by wood ashes, was encouraged for cleanliness. The benefits of bathing were fully known to the ancients, who built elaborate bathhouses. Bathing became less popular in Western cultures during the Middle Ages but again became accepted during the eighteenth and nineteenth centuries.

The use of fragrant substances has been continuous, and the use of lipids or emollients for anointing is fully documented in historical writings. However, it is probably not justifiable to identify the recipes passed on from antiquity as cosmetics. The compositions based on folklore and mysticism were replaced by more scientifically acceptable products beginning about 1875. The first edition of a handbook of cosmetic chemistry published in 1920 included a foreword noting that scientific cosmetic chemistry did not exist prior to that publication (2). A few years later, texts on cosmetic chemistry and other formularies became available (3, 4).

The Society of Cosmetic Chemists, with individual memberships, was founded in the United States after World War II, based on the belief that scientific expertise and exchange were the foundations for future expansion of the cosmetic industry. Prior to that time, knowledge of cosmetic formulation was jealously guarded. Related scientific societies emerged in other countries and have since joined to form the International Federation of Societies of Cosmetic Chemists.

1.3 Regulation of the Cosmetic Industry

In the United States, the 1938 revision of the Federal Food and Drug Act regulates cosmetic products and identifies these materials as:

(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles, except that such term shall not include soap.

This definition establishes the legal difference between a drug and a cosmetic. It is clearly the purpose of, or the claims for, the product, not necessarily its performance, that legally classifies it as a drug or a cosmetic in the United States. For example, a skin-care product intended to beautify by removing wrinkles may be viewed as a cosmetic because it alters the appearance and a drug because it affects a body structure. Different laws and regulations apply to each type of product. Firms sometimes violate the law by marketing a cosmetic with a drug claim or by marketing a drug as a cosmetic without adhering to requirement for drug. The term cosmeceutical used to mean a product that has two functions has no meaning under the law (5).

The FDA is responsible for enforcing the 1939 act as well as the Fair Packaging and Labeling Act. In light of the difficulty of differentiating between cosmetics and drugs, the FDA has in recent years implemented its regulatory power by concluding that certain topically applied products should be identified as OTC drugs. As a group, these OTC drugs were originally considered cosmetics and remain among the products distributed by cosmetic companies. They include acne, antidandruff, antiperspirant, astringent, oral-care, skin-protectant, and sunscreen products.

The use or presence of poisonous or deleterious substances in cosmetics and drugs is prohibited. The presence of such materials makes the product “adulterated” or “misbranded” and in violation of good manufacturing practices (GMP), which are applicable to drugs and, with minor changes, to cosmetics (6).

In contrast to prescription drugs, OTC drugs and cosmetics are not subject to preclearance in the United States. However, the rules covering OTC drugs preclude introduction of untested drugs or new combinations. A “new chemical entity” that appears suitable for OTC drug use requires work-up via the new drug application (NDA) process. In contrast, the use of ingredients in cosmetics is essentially unrestricted and may include less well-known substances.

1.3.1 Color Additives

The FDA has created a unique classification and strict limitations on color additives. Certified color additives are synthetic organic dyes that are described in an approved color additive petition. Each manufactured lot of a certified dye must be analyzed and certified by the FDA prior to usage. This regulation is covered by the Federal Food Drug and Cosmetic Act. Color lakes are pigments that consist of an insoluble metallic salt of a certified color additive deposited on an inert substrate. Lakes are subject to the color additive regulations of the FDA and must be certified by FDA prior to use. Noncertified color additives require an approved color additive petition, but individual batches need not be FDA certified prior to use.

Hair colorants, the fourth class of color additives, may be used only to color scalp hair and may not be used in the area of the eye. Use of these colorants is exempt, that is, coal-tar hair dyes may be sold with cautionary labeling, directions for preliminary (patch) testing, and restrictions against use in or near the eye. The FDA diligently enforces the rules governing color additives and limits the use of, or even delists colorants deemed unsafe. The list of substances specifically prohibited for use in cosmetics is short.

Under the Fair Packaging and Labeling Act, the FDA has instituted regulations for identifying components of cosmetics on product labels. To avoid confusion, the Personal Care Products Council (PCPC)(formerly CTFA) has established standardized names for about 6000 cosmetic ingredients (1). Rigid U.S. labeling requirements mandate that ingredients be listed in order of descending concentration.

1.3.2 European Regulations

Regulations for cosmetics differ from country to country but, in general, are similar to or patterned after U.S. regulation. Thus, the identification of a cosmetic in the European Community differs only marginally from that in the United States. A 1991 European Economic Community (EEC) [now the European Union (EU)] directive defines a cosmetic as:

any substance or preparation intended for placing in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view to cleaning them, perfuming them, protecting them, keeping them in good condition, changing their appearance and/or correcting body odours.

The EU Directive asserts that cosmetic products must not damage human health when applied under normal or reasonably foreseeable conditions of use. Also, the Directive states that the label of a cosmetic should include a list of ingredients in descending order of weight at the time of manufacture.

The 27 EU members have transposed the European Union Directive enacted in 1976 into law. Each member state has health authorities that can regulate cosmetics within the state's boundaries. The EU Scientific Commi...

Table of contents

• Cover
• Kirk-Othmer Chemical Technology of Cosmetics
• Title Page
• Copyright
• Preface
• Part I: Products
• Part II: Ingredients
• Part III: Formulation Technology
• Part IV: Regulatory
• Index