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Colouring agents in cosmetic products(excluding hair dyes)-regulatory aspects and analytical methods

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Moreover, colouring agents may be used to colour the cosmetic products.The aim of this section is to review regulatory information concerning colouring agents prod-in cosmetic products,

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4.2 Colouring Agents in Cosmetic Products

and Analytical Methods

A Weisz*, S.R Milstein and A.L Scher

Office of Cosmetics and Colors, HFS-106, Center for Food Safety andApplied Nutrition, U.S Food and Drug Administration, College Park,

MD 20740, USA

INTRODUCTION

As mentioned in Section 4.1, application of colour is the main purpose of many cosmetic ucts such as lipsticks, blushers, eye shadows, eyeliners, and nail polishes All of these productscontain one or more colouring agents—dyes, pigments or other substances—for providing thedesired colours Moreover, colouring agents may be used to colour the cosmetic products.The aim of this section is to review regulatory information concerning colouring agents

prod-in cosmetic products, as well as the methodologies prod-involved prod-in their analysis Chemicalsused as hair dyes are reviewed in Sections 4.3 and thus will not be considered here

REGULATORY ASPECTS OF COLOURING AGENTS IN COSMETIC PRODUCTS

Colouring agents are subject to a wide range of regulatory restrictions across countries Asmentioned in Section 1.1, positive lists of colouring agents that may be used in cosmeticproducts have been published by three main regulatory authorities—U.S Food and DrugAdministration (FDA) in the United States, the European Commission in the EuropeanUnion (EU), and the Ministry of Health, Labor and Welfare in Japan Other countries per-mit colouring agents approved in the U.S and/or the EU with certain variations

The number and identity of colouring agents permitted for cosmetic use varies amongcountries Table 4.2.1 shows the number of these ingredients listed for use in cosmeticproducts by the three aforementioned regulatory authorities

United States regulatory requirements for colouring agents

In the U.S., colouring agents are known as colour additives, which must comply withrequirements of the U.S Food, Drug, and Cosmetic Act (FD&C Act) and its implementing

* Corresponding author E-mail: adrian.weisz@fda.hhs.gov

153

Analysis of Cosmetic Products

Amparo Salvador and Alberto Chisvert

Copyright © 2007 by Elsevier B.V

All rights of reproduction in any form reserved

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regulations The term colour additive is defined in section 201(t) of the FD&C Act as “(…)

a material which (A) is a dye, pigment, or other substance made by a process of synthesis

or similar artifice, or extracted, isolated, or otherwise derived, with or without ate or final change of identity, from a vegetable, animal, mineral, or other source, and (B) when added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable (alone or through reaction with other substance) of imparting a colour thereto (…) The term ‘colour’ includes black, white, and intermediate grays”.

intermedi-Colour additives permitted in the U.S are classified from a regulatory standpoint as thosesubject to batch certification by the FDA and those exempt from certification Certifiablecolour additives (see Tables 4.2.2–4.2.9) include a variety of mainly synthetic aromatic organicchemicals (also know as coal-tar colouring agents) These colour additives are batch-certified

by FDA to ensure that their composition is in compliance with the identity and specifications

in Title 21 of the U.S Code of Federal Regulations (21 CFR) in order to protect the public’shealth FDA assigns a unique certification lot number to each certified batch However, as dis-cussed in Section 4.3, coal-tar colouring agents used in hair dyes may be exempt from this cer-tification The certifiable colours are listed in 21 CFR Part 74 (straights and a few lakes) and

in 21 CFR Part 82 (most lakes) The definitions of straight and lake are given in 21 CFR 70.3(j)and (l), respectively, and in brief state that a lake is a straight colour extended on a substrate byadsorption, coprecipitation or chemical combination excluding any combination made by asimple mixing process Modified definitions were proposed for these terms in the U.S FederalRegister (61 FR 8372-8417, 1996) but have not yet been officially adopted Certification-exempt colour additives (see Table 4.2.10) include a wide variety of substances that are derivedfrom inorganic, plant, or animal sources, and they are listed in 21 CFR Part 73

Certifiable and certification-exempt colour additives must undergo the FDA pre-marketapproval process in order to be listed A proposal to list a new colour additive or new uses of

a colour additive is made by petition to the FDA as described in 21 CFR Part 71 Descriptions

of the approval process can be found on the FDA website (see references) The listing lations describe the identity of each colour additive, specifications, uses and restrictions,labeling requirements, and the requirement for or exemption from batch certification Inaddition, a regulation must specifically authorize use of the colour additive in the area of theeye (21 CFR Section 70.5(a)), in injections (21 CFR Section 70.5(b), currently, no colouradditive is listed for use in injections), and in surgical sutures (21 CFR Section 70.5(c))

regu-154 4 Colouring Agents in Decorative and other Cosmetics Analytical Methods

Table 4.2.1

Number of colouring agents permitted for use in cosmetics by

the three main regulatory authorities Country Number of colouring agents permitted

aFDA 21 CFR Parts 73 and 74.

bAnnex IV, Part 1 of the EU Cosmetics Directive (Council Directive 76/768/EEC and its amendments)

cOrdinance No 30/1966 from MHW (as amended by MHLW Nos.

55/1972 and 126/2003) (Rosholt, 2003).

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HO NaO3S

R1 N N R2

(Continued )

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Brilliant Lake Red R

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Sunset Yellow FCF

HO

SO3Na NaO3S

N N NaO2C

SO3Na HO

NaO3S

HO

SO3Na NaO3S

H3C

H3C O

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Table 4.2.3

U.S certifiable disazo colour additives for cosmetic use Bis azo-enol structure

Resorcin Brown

Sudan III Toney Red

HO

CH3

CH3OH

OH NaO3S

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4.2 Colouring Agents Regulatory Aspects and Analytical Methods 159

Table 4.2.4

U.S certifiable triphenylmethane colour additives for cosmetic use

Triphenylmethanium resonance

structures

(sodium salt)

CI Food Blue 2 Brilliant Blue FCF

(ammonium salt) Alphazurine FG Erioglaucine

Fast Green FCF

aNames assigned by FDA after certification, and listed in 21 CFR Part 74.

bNot used in the U.S for the names of certified colour additives.

cColour Index (CI) number Not used in the U.S for certified colour additives.

dChemical Abstracts Service (CAS) number.

N

FDA considers cosmetic products to be neither adulterated nor misbranded when theyare in compliance with the requirements of the FD&C Act and its implementing regula-tions, as well as other applicable laws and regulations A cosmetic product (with the excep-tion of coal-tar hair dyes, discussed in Sections 4.3) containing an unlisted colour additive

or a listed colour additive that does not conform to the requirements of its listing tion is considered adulterated under the provisions of sections 601(e) and 721(a) of theFD&C Act

regula-In the U.S., cosmetic products that are offered for retail sale are subject to the provisions

of the Fair Packaging and Labeling Act (FPLA) Under the authority of the FPLA, 21 CFRSection 701.3 requires the label of a cosmetic product to bear a declaration of the ingredi-ents, usually in descending order of predominance, as mentioned in Section 1.2 However,

21 CFR Section 701.3(f) states that colour additives are permitted to be declared as a group

at the end of the ingredient statement, without respect to order of predominance Thisrequirement for colour additive labeling does not apply to professional-use-only (or salon)products unless specifically required by regulation In addition, colour additives that arenot present in shaded products or products with similar composition and that are intendedfor the same use may be included in the label by preceding the colour additive name with

“may contain” (21 CFR Section 701.3(g))

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160 4 Colouring Agents in Decorative and other Cosmetics Analytical Methods

Table 4.2.5

U.S certifiable fluoran colour additives for cosmetic use

Fluoran structure

D&C Orange No 5 CI Solvent Red 72 45370:1 596-03-2 ⫺H ⫺Br ⫺H

Dibromofluorescein D&C Orange No 10 CI Solvent Red 73 45425:1 38577-97-8 ⫺H ⫺I ⫺H

Diiodofluorescein D&C Red No 21 CI Solvent Red 43

Tetrabromofluorescein 45380:2 15086-94-8 ⫺Br ⫺Br ⫺H D&C Red No 27 CI Solvent Red 48

Tetrabromotetrachlorofluorescein 45410:1 13473-26-2 ⫺Br ⫺Br ⫺Cl D&C Yellow No 7 CI Solvent Yellow 94 45350:1 2321-07-5 ⫺H ⫺H ⫺H

Fluorescein

aNames assigned by FDA after certification, and listed in 21 CFR Part 74.

bNot used in the U.S for the names of certified colour additives.

cColour Index (CI) number Not used in the U.S for certified colour additives.

dChemical Abstracts Service (CAS) number.

As explained in Section 4.1, colour additives may be declared on cosmetic labels either

by their listed names or, for certifiable colour additives, by abbreviated names formed byomitting “FD&C” or “D&C” and “No.” but including “Ext.” and “Lake” FDA has stated

that the agency “(…) does not intend to object to the immediate use of abbreviated labeling

for declaring the presence of certified colour additives in cosmetics (…)” (FDA, 1999).

Both the FD&C Act and FPLA provide authority to FDA to regulate the labeling of metic products Failure to comply with the requirements for cosmetic labeling may render

cos-a cosmetic cos-adultercos-ated under section 601 of the FD&cos-amp;C Act or misbrcos-anded under section

602 of the FD&C Act

Regulatory requirements for the marketing of cosmetics in the U.S have been presented

previously (Milstein et al., 2006) Further details about colour additives permitted in the

U.S may be found on the FDA website (see references)

EU regulatory requirements for colouring agents in cosmetic products

Within the EU Cosmetics Directive (i.e Council Directive 76/768/EEC), all colouringagents, except those intended to colour hair, and their field of application and other

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4.2 Colouring Agents Regulatory Aspects and Analytical Methods 161

Table 4.2.6

U.S certifiable xanthene colour additives for cosmetic use

Xanthene structure

Erythrosine Yellowish Na

Eosin Y

Phloxine B Cyanosine

Uranine

aNames assigned by FDA after certification, and listed in 21 CFR Part 74.

bNot used in the U.S for the names of certified colour additives.

cColour Index (CI) number Not used in the U.S for certified colour additives.

dChemical Abstracts Service (CAS) number.

D&C Yellow No 10 CI Acid Yellow 3 47005 8004-92-0 Mixture of

SO3Na D&C Yellow No 11 CI Solvent Yellow 33 47000 8003-22-3 ⫺H

Quinoline Yellow SS

aNames assigned by FDA after certification, and listed in 21 CFR Part 74.

bNot used in the U.S for the names of certified colour additives.

cColour Index (CI) number Not used in the U.S for certified colour additives.

dChemical Abstracts Service (CAS) number.

N 6'

8'

O

O R

H

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Alizarine Cyanine Green F

HN

CH3NaO3S

HN

CH3NaO3S

O

O R1

R2

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U.S certifiable nitro, pyrene, thioindigoid, and carbon colour additives for cosmetic use

ONa NaO3S N +

CH3 O

CH3O

SO3Na

SO3Na NaO3S

HO

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U.S certification-exempt colour additives for cosmetic use

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on Al(OH)3of aqueous extract

of cochineal)d

-Carotene (synthetic 40800 7235-40-7

OH HO

O

CO 2 H O

HO OH OH

HO

CH 3

O

O OH

O

CO 2 H O

OH

HO OHHO

CH 3

Al OH Ca2+, H 2 O

H 2 O

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O OH

HN

N N H

H2N O

O

N N O O O

O O

O

Na Na

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Lead acetatef,g — 6080-56-4 Pb(O2CCH3)2· 3H2O

fNot permitted in Japan.

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requirements are listed under Annex IV It should be emphasized that in the EU Inventory

of Cosmetic Ingredients (Commission Decision 2006/257/EEC), colouring agents are

divided into cosmetic colorants, which “colour cosmetics and/or impart colour to the skin

and/or its appendages” and hair dyes, which “colour hair” As mentioned previously, hair

dyes are described in Sections 4.3, and are not the subject of this section

According to EU Cosmetics Directive, as previously mentioned in Section 1.2, labels ofcosmetic products marketed in the EU are required to declare their ingredients in descend-ing order of predominance using the INCI names However, colouring agents may be listed

in any order after other components As previously mentioned in Section 4.1, they are listed

in EU Cosmetics Directive Annex IV by their Colour Index (CI) number or denomination,which are INCI names for these cosmetic ingredients In the special case of decorative cos-metic products marketed in several colour shades, all colouring agents used in the collec-

tion may be listed, provided that the words “may contain” or the symbol “+/⫺” are added

As mentioned in Section 1.2, Annex IV is divided into two parts: Part 1 lists colouringagents that are currently allowed for use in cosmetics; whereas Part 2, for provisionallyallowed colouring agents, is empty Footnote 1 to Annex IV permits the lakes or salts ofthe permanently listed straight colouring agents also to be used as cosmetic ingredientsprovided they are prepared from substances not prohibited under Annex II or excludedunder Annex V of the EU Cosmetics Directive The lakes or salts have the same CI num-bers as the corresponding straight colouring agents

Japan regulatory requirements for colouring agents in cosmetic products

In Japan, colouring agents are named as colorants As mentioned in Section 1.2, a positivelist for synthetic organic colorants was created for the first time in 1966 by the Ministry ofHealth and Welfare (MHW, 1966), and amended by the Ministry of Health, Labor, andWelfare (MHLW) in 1972 and 2003 As mentioned in Section 4.1, Japan uses alternateINCI names for colouring agents in the cosmetics marketed in Japan These Japanesenames differ from the U.S and EU names

It should be emphasized that only synthetic organic (or coal-tar) compounds are listed

as colorants by MHLW These colorants do not need to be certified, but they must conform

to specifications Inorganic, plant, and animal substances are regulated as cosmetic dients, but may be used as colorants

ingre-Other international regulatory requirements for colouring agents

Many countries have enacted legislation and issued regulations for approving and listingcolouring agents and declaring colouring agents on the labels of cosmetics Rosholt (2003)presents detailed discussions of specific requirements, by country Other countries havechosen approaches to control the use of colouring agents in cosmetics that reflect, to agreater or lesser extent, either the U.S or EU regulatory models Otterstätter (1999) notesthat this is done in some cases by incorporating into national regulations reference to lists

168 4 Colouring Agents in Decorative and other Cosmetics Analytical Methods

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4.2 Colouring Agents Regulatory Aspects and Analytical Methods 169

of approved colouring agents that are virtually identical to the lists of the U.S or the EU.Alternatively, some countries adopted parallel regulatory approaches for the approval ofsuch colouring agents, whereby equivalence can be established

Some countries require colouring agents to be declared on the labels of cosmetic ucts in their primary national language(s) Cosmetics also may have ingredient labeling inseveral languages if they are marketed in more than one country

prod-U.S and EU international harmonization efforts for cosmetic labeling

The use of CI numbers has been an approach for harmonizing the declaration of colouradditives in cosmetic products marketed in the Member States of the EU As was also men-tioned in Section 4.1, the Cosmetic, Toiletry, and Fragrance Association (CTFA) requested

in 1995, in the interest of international harmonization, that FDA permit the use of dual laration of colouring agents on the labels of cosmetic products marketed in the U.S Dualdeclaration of a colouring agent would consist of the U.S listed name followed by the CInumber in parentheses CTFA requested that FDA permit such dual labeling in the interimwhile the agency considered a citizen petition requesting that the colour additive regula-tions be amended to permit such labeling In response, in a June 1, 1995 letter to CTFA,FDA stated that the agency “would be unlikely to object” to such interim use of dual dec-larations of colour additives on the labels of cosmetic products (FDA, 1995)

dec-FDA also stated that manufacturers of finished cosmetic products (other than hair dyes)intended for sale in the U.S should be alerted that, although a dual declaration for the colouradditive name might be used for cosmetic labeling purposes, U.S law requires the use ofonly colour additives in their products that are in full compliance with applicable regulations.The use of an uncertified, and therefore unapproved, colour additive subject to batch certifi-cation in a cosmetic renders such product adulterated within the meaning of the FD&C Act

DETERMINATION OF COLOURING AGENTS The importance of determining colouring agents in cosmetic products

This section describes several reasons for determining colouring agents in cosmetic ucts The determinations have regulatory, forensic, or manufacturing significance as pre-sented below

prod-(a) To ensure that only permitted colouring agents are added to the cosmetic product

As was shown earlier, colouring agents permitted in one country are sometimes notapproved in others For example, erythrosine is permitted in cosmetics as a colouring agent

in the EU (as CI 45430) and as a colorant in Japan (as Aka3), but it is not permitted foruse in cosmetics in the U.S (21 CFR 81.30(u))

A different case is the colouring agent Quinoline Yellow This quinoline-type dye consists

of a mixture of mono-, di-, and trisulfonated positional isomers, the relative proportions of

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which depend on the degree of sulfonation obtained during its manufacture A mixture of themonosodium salts of the 6⬘- and 8⬘-monosulfonic acids with up to 15% of the disodium salts

of the disulfonated isomers is certifiable in the U.S as the colour additive D&C Yellow No

10 (Table 4.2.7) (21 CFR 74.1710) A mixture that contains mostly di- and trisulfonated ponents is permitted as a cosmetic colouring agent in the EU (as CI 47005) and as a colorant

com-in Japan (as Ki203) (see Rosholt, 2003) Even though both of these variant forms are com-indexed

as CI 47005, the latter mixture (i.e consisting mainly in di- and trisulfonated components)

is not certifiable in the U.S and is therefore not permitted in cosmetics that are imported andsold in the U.S

(b) To ensure that the information on the label is complete and correct

In U.S., for example, the colouring agents that are part of a cosmetic product must bedeclared by name on the product’s label (21 CFR Section 701.3) Analysis of the cosmeticmay find undeclared certified or certification-exempt colour additives If the information

is not complete or not correct, the product is misbranded and may also be adulterateddepending on what is found

(c) To determine the cause of allergic and dermatologic reactions

Contact of the human body with certain colouring agents, their impurities, or their position products (that may occur during processing or storage of the cosmetic product)can produce allergic reactions, sensitization, or photosensitization in susceptible people

decom-(Rosenthal et al., 1988; Wei et al., 1994, 1995; Mselle, 2004; Antonovich and Callen, 2005; Klontz et al., 2005) Determination of the colouring agent(s) present in the cosmetic

product used may provide a clue to the source of the unexpected reaction

(d) To help in forensic investigations

Lipstick smears left on drinking glasses, cups, and cigarette butts can link a suspect to acrime scene When found on a suspect’s clothing, they can prove a link between the sus-pect and victim Results obtained from the analysis of lipstick smears in a forensic sciencelaboratory are often found to be important evidence in criminal cases (Barker and Clarke,

1972; Andrasco, 1981; Russel and Welch, 1984; Gennaro et al., 1994; Griffin et al., 1994; Ehara and Marumo, 1998; Rodger et al., 1998).

(e) To determine the stability of a colouring agent added to various matrices

The stability of a colouring agent can be affected by many factors during storage of thecosmetic product Such factors are light, heat, pH, nature of the packaging, nature of theproduct base, etc (Rush, 1989; Otterstatter, 1999)

( f ) Quality control

Cosmetic manufacturers must determine colouring agents present in their products in order

to ensure that quality standards are consistently maintained (Rodger, 1998) This quality

170 4 Colouring Agents in Decorative and other Cosmetics Analytical Methods

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