LANDSCAPE IN THE U.S. AND THE E.U. AND HOW TO DEAL WITH THEM…
Dr. Matteo Zanotti Russo
University of Pisa
Angel Consulting SAS – Milano
INTRODUCTION
ABSTRACT
The regulatory part of the “cosmetic world” is certainly one of the less “attractive,” as it is often seen as a boring list of prohibitions and restrictions. The regulatory experts often deal with recurring questions such as: How can one enjoy such a bore? What can motivate the expert on regulatory issues? One can also ask why regulatory issues should be brought to the attention of other company heads and operative managers, such as those responsible for R&D, manufacturing, and stranger still, marketing and sales?
Regulatory issues affect many business activities, such as development, production, marketing, and sales. Knowledge of the regulations must be passed across the company organization chart (of course at different levels of knowledge). No doubt the knowledge of “how” we should interpret and apply the rules, as well as protect consumers and the company, can be a competitive advantage, because an optimal application of complex regulatory issues (i.e., the optimal management, as well as the interpretation and the application) allows the company to achieve the objectives in a leaner and more efficient manner.
This chapter has the intention of meeting a variety of different needs at the same time: experts will appreciate the many updates described below, while beginners (or “outsiders”) will find it useful as “introductory” reading. However, in view of the changing character of regulations, and using the fundamentals described below, the author highly recommends followup reading and study of the (irreplaceable) of the laws in the full version. If you are not a regulatory expert, we recommend that you retain one or have one in your company.
2.2.1 The challenge of “changing standards”
2.2.2 Regulatory Requirements for Cosmetics in the United States
a. Introduction: roles and responsibilities
c. Definition of Cosmetic, field of application, drugs and
cosmetics, cosmeceuticals
d. Classification of Cosmetic/Drug
e. How to manage Cosmetic/Drug
g. Labeling and package of cosmetics
i. Missing INCI name; what to do
j. How to get the assignment of a new INCI name
2.2.3 Guide to Cosmetic Development and Safety Evaluations
a. Compliance of limited/regulated ingredients
b. Safety assessment of cosmetics according to FD&C Act
c. Regulated/limited substances
d. Prohibited ingredients and impurities according to the FDA
f. Safety profile of substances: source of information
g. Safety profile of finished product
h. Microbiological requirement
i. Activity of manufacturers/importers/exporters
j. FDA plant inspection checklist
k. Activity of public health authorities:
notification/permissions, audits
l. Future developments of U.S. legislation
2.2.4 Regulatory Requirements for Cosmetics in the European Union
a. Introduction, roles, and responsibilities
b. “Intercontinental” products
c. Classification of cosmetic/drug, borderline products
g. Troubles on EU INCI names, and what before
and after the “Glossary”
i. Manufacture of cosmetics for the European market
2.2.5 PIF and safety assessment of European cosmetics
a. Profile of the safety assessor
d. Annexes that have to be considered: II to VI
2.2.6 Safety profile of substances: source of information
2.2.7 The safety assessment from raw material to finished product
2.2.8 The Notification in the CPNP
2.2.9 Market Surveillance, activity of EU Authorities (Articles 22–23), RAPEX
a. Other laws that affect the EU 1223/2009: REACH
(EU regulation on chemicals)
2.2.10 Practical features: how to move towards compliance with EU regulations
2.2.1 THE CHALLENGE OF “CHANGING STANDARDS”
The “world” of cosmetic products reveals constant surprises to those who approach it (and often even to those who have attended for a long time): creative research of beauty and the pursuit of ideal beauty and wellness are part of a complex and fascinating world, so anyone who begins to study the scientific formulation soon discovers that products like cosmetics (apparently simple mixtures of well-known ingredients) hide enormous difficulties that require a thick scientific basis.
“Simple mixtures of substances,” a real worry for experts and authorities
Cosmetic products, from the regulatory point of view, represent a real challenge: they are widely divulged, freely used by the consumer without theoretical limits of time, and may be subject to many problems, such as contamination by harmful substances (sometimes present in the ingredients), or microbiological contamination due to misuse, inadequate description, or unsuitable packaging.
The extension of use to millions of consumers amplifies the size of the potential issues, and hence, the need for very articulate legislation. The turnover of products, moreover, is very high, and the demand for novelty is constant. It is therefore not strange that the U.S. and the European Union have taken a long time (in Japan since 2001) to form a system of laws based on the liability of a person placing a product on the market and on verifying postmarketing instead of the registration / approval premarketing that is usually allowed for pharmaceutical products.
New tools and approaches in communications: usefulness and limitations of the Web
In recent years, communication systems and social networks have undergone changes and updates, thanks to the use and diffusion of innovative and revolutionary hardware tools (tablets and smartphones). At the same time the World Wide Web and web pages of companies and institutions have changed the style and purpose of Internet pages. Overlap and mutual influence of these two factors have resulted in a huge facility in communication between consumers, businesses, institutions, and transversely between all these stakeholders.
The web pages of companies and institutions include areas of news and the ability to share information and interact in both directions, as well as systems for notification of cosmetic products in the EU (below the EU database CPNP will be shown) and the U.S. (i.e., the VCRP, the Volontary Registration Program headed to FDA). These concern data uploading in electronic databases. Anomalies in the market are published directly on institutional sites (see below in the EU rapid alert system, RAPEX [G]): the web has often become the tool for updates and for the exchange of information, and the following paragraphs will highlight the most useful sites to consult for further information on the topics.
At the same time, cosmetic companies must consider the fast speed of distribution of opinions and comments. Unfortunately it is hard for the typical user to distinguish between different sources of information and understand their reliability, while there is no doubt the influence that is produced by the diffusion of information through the Web. True or false, information makes a big impact. Accordingly, spreading of information before products are tested and officially approved by the authorities may produce important effects on the market, because of the ease of sharing. There are therefore good reasons to increase the threshold of attention to regulatory aspects.
Cosmetic regulations in the world
Is the search for an “ideal” regulatory model a utopian dream? Most countries are adapting their standards to a changing market; the priority is to find a system that can provide greater protection to the consumer without hindering a lively and expanding market.
2.2.2 REGULATORY REQUIREMENTS FOR COSMETICS
IN THE UNITED STATES
a. Introduction: roles and responsibilities
The fundamental principles of legislation affect not only to the workflow, but also market developments: cosmetic legislation of each country is based on finding this balance between controls and the lean development of new products. Many of the international regulations are based on common principles: product liability lies with the company, while institutions determine basic rules and criteria for control of the market through the application of legal restrictions and the publication of guidelines: U.S. legislation adopted this principle in 1938; in 1976 the European Commission published Directive 76/768, inspired (with considerable differences) by the same principle of self-referentiality; and Japan adapted its legislation to this approach with the “deregulation” of 2001 (given the original “pharmaceutical” setting based on premarket authorization and positive list of ingredients).
U.S. legislation on cosmetic products is thus based on the principle of “empowerment” of the person who places the cosmetics on the market and is expected to know and apply the rules in force and to ensure the safety and proper labeling of the product. With the exception of a list of prohibited substances and restricted substances, any ingredient is permitted, as long as the cosmetic product placed on the market is safe and correctly labeled. Cosmetic products (produced or imported in the U.S.), cosmetic ingredients, and production facilities are subject to inspections by the FDA, because they all have to comply with the same rules and standards.
The Cosmetic law then determines the identification of the cosmetic product, labeling procedures, and substances prohibited/regulated. The authorities (FDA) provide the guidelines for compliance and acts as a monitor of the market, while those responsible for placing on the market (the Cosmetic firm) must ensure compliance of the product and the security, assuming the responsibility.
The main regulations for the management of cosmetic products in the U.S. are the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA), which concern respectively the compliance criteria and the criteria for labeling of cosmetics and sustainability claims given by the authorities of the Food and Drug Administration (known worldwide as the FDA).
In particular the FD&C Act, Chapter VI – Cosmetics, concerns the following important subchapters, in which the succinct description focuses on the characteristics and changes that cosmetics “cannot” have:
Sec 601 – Sec 361 – Adulterated cosmetics
Sec 602 – Sec 362 – Misbranded cosmetics
The approach based on self-control and responsibility of companies is evidenced by the lightness of the regulatory structure, which with a few dozen pages may regulate a sector that is very articulated and innovative.
An adulterated cosmetic:
– bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under conditions of use as are customary and usual” [with an exception made for hair dyes];
– consists in whole or in part of any filthy putrid, or decomposed substance”;
– has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health”;
– has a container composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health” or
– except for hair dyes, “it is, or it bears or contains, a color additive which is unsafe within the meaning of section 721 (a)” of the FD&C Act (FD&C Act, sec. 601)
As for a misbranded cosmetic:
– its labeling is false or misleading in any particular;
– its label does not include all required information;
– the required information is not revealed with adequate prominence and conspicuousness;
– its container is so made, formed, or filled as to be misleading;
– it is a color additive, other than a hair dye, that does not conform to applicable regulations issued under section 721 of the FD&C Act, and
– its packaging or labeling is in violation of an applicable regulation issued pursuant to section 3 or 4 of the Poison Prevention Packaging Act of 1970. (FD&C Act, sec. 602)
c. Definition of Cosmetic, field of application, drugs and cosmetics, cosmeceuticals
The FD&C act, Sec. 321, Title 21 provides the definition of cosmetic product:
The term “cosmetic” means (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.
The cosmetic product can thus generate a “physical” and not “physiological” function. When the product exerts a cosmetic function as well as treats or prevents disease or otherwise affects the structure or any function of the human body, then it can be classified as a Drug (Sec. 201 [g] and [i], FD&C Act Sec 509), and the product must simultaneously meet the requirements of cosmetics and drugs (for all aspects relating to the composition, production, and labeling).
According to U.S. laws the products of “personal care” can then be classified as cosmetics, drugs, or cosmetics/drugs, while being officially disavowed by the FDA definition of “cosmeceuticals,” which had a fairly widespread claims in advertising: it does not correspond to any new category, as the cosmetic product that is able to exercise significant physiological interactions is automatically a drug or a cosmetic/drug combined.
Examples of cosmetic / drug are: anti-dandruff shampoos and antiperspirant-deodorants, as well as toothpastes that contain fluoride, deodorants that are also antiperspirants, moisturizers and makeup with SPF (sun protection factor) numbers.
d. Classification of Cosmetic/Drug
Based on the definition given by the law, it should be noted that the classification of a product as “cosmetic” or “cosmetic/drug” depends on the “intended use” and not only by the composition, although it is clear that the presence of certain substances whose action is recognized (such as fluorine or UV filters), automatically produces the classification as “cosmetic/drug.” The main factors that determine the intended use are:
- ● product labeling, in advertising, on the Internet, or in other promotional materials
- ● consumer perception (product reputation)
- ● ingredients (known for their action)
In other words, a cosmetic that “induces” a use or function compatible with the definition of “drug” is classifiable as a “drug” regardless of the presence of active substances, and typical claims that in the opinion of the FDA produce a classification as a drug are: hair growth restoration, cellulite reduction, varicose vein treatments, whiteners (melanin reduction) or darkening (melanin increase), cell regeneration in the skin.
e. How to manage Cosmetic/Drug
The simultaneous classification Cosmetic/Drug also involves other important aspects that should be considered and applied, concerning the whole workflow:
– the drug requiring premarket approval through the procedure NDA (New Drug Application, [FD&C Act, sec. 505 (a) and (b)]) or must comply with the monographs established by FDA’s Over-the-Counter (OTC) Drug Review;
– production of the drug is subject to the rules of Good Manufacturing Practice defined (Title 21 of the Code of Federal Regulations [CFR], parts 210 and 211 ), while for cosmetic products (as you will see below) the GMP have been defined in the form of guidelines;
– registration of cosmetic products is not mandatory (see below the Voluntary Cosmetic Registration Program, VCRP), while the drug must be registered with the Drug Registration and Listing System [FD&C Act, sec. 510, 21 CFR 207] (DRLs and eDRLS);
– labeling of the drug is regulated by OTC drug regulations, including the “Drug Facts” labeling, as described in 21 CFR 201.66, which must be integrated into the labeling cosmetics. For example, you need to identify the “active ingredients” followed by cosmetic ingredients identified as “inactive ingredients.”
According to the definition of cosmetic given by the FD&C Act, soaps are not classified as cosmetics, but are regulated by the Consumer Product Safety Commission (CPSC), and not by the FDA. Soap, as defined by the FDA, is characterized by:
– the bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids, and the product’s detergent properties are due to the alkali-fatty acid compounds, and
– the product is labeled, sold, and represented solely as soap [21 CFR 701.20].
However, the definition of soap can be a source of confusion, because soap cannot be accompanied by other ingredients intended as cosmetic; otherwise it will be classified and labeled as cosmetic, as in the case of fragrances or moisturizers, or functioning as a deodorant. Also, any product that is intended solely for the human body, that appears as a soap but does not consist primarily of alkali salts of fatty acids, may be identified and named as a soap but will be regulated and labeled as a cosmetic.
g. Labeling and package of cosmetics
Principal Display Panel:
- ● Name of product
- ● Identity
- ● § 740.10 warning
- ● Net quantity of contents
Information Panels:
- ● Directions for safe use
- ● Warnings
- ● Name and place of business
- ● Ingredient declaration
- ● Any other required information
Under the FP&L Act, Sec. 10(b), 21 CFR 1.20, the Package is: a container or wrapping, other than a shipping container or wrapping, in which a consumer commodity is delivered or displayed to retail purchasers.
The labeling of cosmetics is regulated simultaneously by the FD&C Act and the Fair Packaging and Labeling Act, where the latter is intended to ensure that packaging and labels provide the consumer with the correct information about the content and to facilitate the comparison with other similar products; at the same time, the FD&C Act prohibits the production and sale of misbranded products.
The setting of the cosmetic product labeling concerning the identification of the front panel, side panels, and back panels of the outer package, where we identify the Principal Display Panel (PDP front, the immediately visible to the consumer) and the Information Panel (all others).
According to the FP & L Act, Sec 10 (t), 21 CFR 701.10, the PDP is:
That part of the label the consumer sees or examines when displayed for retail sale.
Under the legislation, certain information must be visible and legible on the PDP while other information may be made on the Principal Display Panel:
- ● Name of product (common or usual name or picture)
- ● Identity
- ● § 740.10 warning
- ● Net quantity of contents (within the bottom 30% of the PDP)
on the Information Panels:
- ● Directions for safe use
- ● Warnings
- ● Name and place of business (manufacturer, packer, or distributor, corporate name, street or phone number, city, state, and ZIP)
- ● Ingredient declaration
- ● Any other required information
Inner Container
In the case in which a product is contained in an outer container, some information should be given about the inner container:
Front Panel:
- ● Name of product (common or usual name or picture)
Information Panels:
- ● Directions for safe use
- ● Warnings
- ● Name and place of business (manufacturer, packer or distributor, corporate name, street or phone number, city, state, and ZIP)
- ● Net quantity of contents
- ● Any other required information
Prominence and conspicuity
Regulations published by the FDA [21 CFR 701.2] on prominent and conspicuous placement of information:
- ● Panel display: The required information must be on a panel that is presented or displayed under customary conditions of purchase. This eliminates placement of required information on a bottom panel of a cosmetic unless it is very small and customarily picked up by hand where inspected for possible purchase.
- ● Panel size: The label must be large enough to provide sufficient space for prominent display of the required information.
- ● Style and size of letters: The type must be of such size, and at least of the required minimum size, and of such style that the required label statements are easily readable.
- ● Background contrast: The contrast must be sufficient to make the required label statements conspicuous and easily readable.
- ● Obscuring designs, vignettes: The required statements must not be obscured by vignettes or other designs or by crowding with other printed or graphic matter.
Letter size on labels
Ingredient Declaration [21 CFR 701.3(p)]: Generally, in letters not less than 1/16” in height [21 CFR 701.3(b)]. If surface area available to bear label (excluding surfaces with decorative relief, sculptured surfaces) is less than 12 square inches, letter height may be not less than 1/32”.
Net Contents Declaration on PDP [21 CFR 701.13(e) and (i)]: Minimum letter height determined by the area of the PDP. In the case of “boudoir-type” containers, including decorative cosmetic containers of the cartridge, pill box, compact or pencil type, and cosmetics of 1/4 oz. or less capacity, the type size is determined by the total dimensions of the container. If the container is mounted on a display card, the display panel determines the letter height.
Warning Statements [21 CFR 740.2]: Type size no less than 1/16” unless smaller size established by regulation .
Letter Height[21 CFR 701.13(h)]: The lower case letter “o” or equivalent when upper- and lowercase letters are used.
The regulations of the FD&C Act provide for the mandatory warning in the following cases:
- ● Cosmetics with Unsubstantiated Safety (21 CFR 740.10): Warning—The safety of this product has not been determined.
- ● Cosmetic Aerosols (21 CFR 740.11 [a]): Warning—Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F. Keep out of reach of children.
- ● Cosmetic Aerosols (21 CFR 740.11 [b]): Warning—Use only as directed. Intentional misuses by deliberately concentrating and inhaling the contents can be harmful or fatal.
- ● Feminine Deodorant Sprays (21 CFR 740.12): Caution—For external use only. Spray at least 8 inches from skin. Do not apply to broken, irritated, or itching skin. Persistent, unusual odor or discharge may indicate conditions for which a physician should be consulted. Discontinue use immediately if rash, irritation, or discomfort develops.
- ● Foaming Detergent Bath Products (21 CFR 740.17):
1) product not clearly intended for adult use only:
Caution—Use only as directed. Excessive use of prolonged exposure may cause irritation to skin and urinary tract. Discontinue use if rash, redness, or itching occurs. Consult your physician if irritation persists. Keep out of reach of children.
2) product clearly intended for adult use only: “Keep out of reach of children” and “For adult use only.”
Cosmetic Ingredient Labeling
On the labels has to be shown:
Declaration of ingredients except flavor, fragrance, and trade secret ingredients in descending order of predominance (21 CFR 701.3)
The exceptions to the descending order, are:
1. If the cosmetic is a drug also, section 502 (c) of the FD&C Act requires that the active drug ingredient (s) be declared before the declaration of cosmetic ingredients. A declaration would thus read as follows: “Active Ingredient: … (Name of drug ingredient). Other (Cosmetic or) Ingredients:… (Names of cosmetic ingredients in descending order).” [§ 701.3 (d)]
2. Ingredients present at a concentration not exceeding 1% may be listed in any order after the listing of the ingredients present at more than 1% in descending order of predominance. [§ 701.3 (f) (2)]
3. Color additives of any concentration may be listed in any order after the listing of the ingredients that are not color additives [§ 701.3 (f) (3)].
4. The name of an ingredient accepted by FDA in accordance with the procedures established in § 720.8 as a trade secret need not be disclosed on the label. In lieu of the name declaring that ingredient, the phrase “and other ingredients” may be used at the end of the ingredient declaration [§ 701.3 (a)].
The reason why the ingredient list is shown on the label (in descending order) derives from the utility to consumers who can choose cosmetic products based on the components and especially those who have a full-blown individual sensitivity or intolerance to one of the ingredients, can avoid any contact. Thus, the legislation of the FD&C Act, as well as almost all international standards, requires the use of a conventional nomenclature, what is identified worldwide as “INCI” (International Nomenclature for Cosmetic Ingredients).
The Article 21 CFR 701.3 (c) provides for the identification of the following possible lists:
- ● The name established by the commissioner as specified in § 701.30
- ● The name adopted for the ingredient as listed in:
- ● CTFA Cosmetic Ingredient Dictionary (now the Personal Care Product Council, CPNP [D])
- ● United States Pharmacopeia
- ● National Formulary
- ● Food Chemical Codex
- ● USAN and the USP Dictionary of Drug Names
- ● The name generally recognized by consumers
- ● The chemical or technical name or description
The most common nomenclature is shown in the Cosmetic Ingredients Dictionary (CID), which is published and updated by the PCPC (former CTFA) [D]. It was updated every two years until 2010 (available as book or CD-ROM), while from 2011 the CID has been offered in a real-time updated list of available items directly on the web (wINCI—Web Based INCI Dictionary), but the real book can still be purchased.
i. Missing INCI name; what to do
The development of new cosmetic products according to the U.S. legislation gives the opportunity to introduce new ingredients (the sector is very dynamic and responsive to innovation), and since according to the law it is not necessary to have specific permissions for the ingredients (except those regulated), it may happen that an innovative ingredient is not associated with an INCI name.
At first, it has to be clarified that the presence of the ingredient in the list CID does not mean that the ingredient is “authorized” (only the dyes require specific authorization of the FDA), since the introduction of ingredients is not restricted at the discretion and under the expert in charge and is the responsibility of the Safety Assessment. Also, the absence of the INCI name from the list does not mean that the ingredient is prohibited. In fact, the FD&C Act (in parallel with almost all international standards, as discussed below) allows the use of alternative identifications, but you still need to implement a strategy to avoid problems, such as the attribution “official” of a CID in the INCI name for the same ingredient, which will be dissonant with respect to the product labels on the market.
j. How to get the assignment of a new INCI name
The request for assignment of a new INCI name can be made online on the website of the PCPC, by INCI application. The procedure is pretty simple; it involves filling out forms and entering data that identify the chemical structure of the new ingredient, impurities and/or solvents, a description of the process of production/purification, and an INCI name proposed by the applicant.
2.2.3 GUIDE TO COSMETIC DEVELOPMENT AND
SAFETY EVALUATIONS
– compliance of limited/regulated ingredients
– safety profile of unregulated ingredients
– testing on final product
a. Compliance of limited/regulated ingredients
As we have seen in the section on labeling in the previous chapter, an important warning is highlighted in bold: products whose safety has not been determined.
Although cosmetics should be safe under intended condition of use, they must have been appropriately evaluated, and if not, the following warning has to be shown:
Warning: The safety of this product has not been determined.
In order to avoid such unseemly words, which, however, do not relieve the “cosmetic firm” from responsibilities towards consumers and authorities, it is necessary that a qualified expert with proven scientific training and experience conclude that the product is not dangerous for consumers under normal and reasonably foreseeable use, based on toxicological and other available data, the chemical composition, and other relevant information.
b. Safety assessment of cosmetics according to FD&C Act
Under the FD&C Act, the safety of the cosmetic must be substantiated by:
a. Reliance on available toxicological data on its ingredients and tests on similar products, and
b. Performance of additional toxicological and other testing deemed appropriate in the light of the existing data.
Although the individual ingredients are safe, FDA recommends performing toxicology tests on the finished product to ensure adequate safety assessment.
Under the FD&C Act it is therefore necessary to proceed on the toxicological findings of the ingredients in order to extend the evaluation to the intended use (and hence exposure to consumer) and complete the evaluation process with toxicological tests on the finished product, according to the process described below.
c. Regulated/limited substances
The first step in the safety assessment of the cosmetic product is certainly the verification of the presence of any substances not permitted or regulated. (21 CFR Parts 250,250 and 700.11 through 700.35).
Ingredients not allowed:
- ● Bithionol photo-contact sensitization (21 CFR 700.11).
- ● Chlorofluorocarbon propellants (21 CFR 700.23).
- ● Chloroform. animal (21 CFR 700.18).
- ● Halogenated salicylanilides (di-, tri-, metabromsalan and tetrachlorosalicylanilide) photocontact sensitization (21 CFR 700.15).
- ● Methylene chloride animal carcinogenicity (21 CFR 700.19).
- ● Vinyl chloride carcinogenicity [21 CFR 700.14].
- ● Zirconium-containing complexes. The use of zirconium-containing complexes in aerosol cosmetic products is prohibited because of their toxic effect on lungs, including the formation of granulomas [21 CFR 700.16].
- ● Prohibited cattle materials. To protect against bovine spongiform encephalopathy (BSE, “mad cow disease”). It does not include tallow that contains no more than 0.15 percent insoluble impurities, tallow derivatives, and hides and hide-derived products, and milk and milk products. [21 CFR 700.27, as amended].
Limited Ingredients:
- ● Hexachlorophene. It may be used only when an alternative preservative has not been shown to be as effective. The HCP concentration of the cosmetic may not exceed 0.1 percent. HCP may not be used in cosmetics that in normal use may be applied to mucous membranes such as the lips [21 CFR 250.250].
- ● Mercury compounds. Eye area cosmetics at less than 65 parts per million (0.0065 percent) of mercury calculated as the metal (about 100 ppm or 0.01 percent phenylmercuric acetate or nitrate) are permitted only if no other effective and safe preservative is available for use. All other cosmetics: Mercury of less than 1 part per million (0.0001 percent) whose presence is unavoidable under conditions of good manufacturing practice [21 CFR 700.13].
- ● Sunscreens in cosmetics. The product will be classified as a drug. However, sunscreen ingredients may also be used in some products for nontherapeutic, nonphysiologic uses (for example, as a color additive or to protect the color of the product). To avoid consumer misunderstanding, if a cosmetic product contains a sunscreen ingredient and uses the term “sunscreen” or similar sun protection terminology anywhere in its labeling, the term must be qualified, in accordance with 21 CFR 700.35(b), by describing the benefit to the cosmetic product provided by the sunscreen ingredient (for example, “contains a sunscreen to protect product color”).
d. Prohibited ingredients and impurities according to the FDA
It should be noted that prohibited and regulated substances are ingredients that are unlikely to be present as “inevitable impurities,” in which case the compliance check is very easy: the forbidden substances are added or consciously avoided (unless the other raw materials are not contaminated or counterfeit with some forbidden substance).
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