The INCI nomenclature system continues the use of ingredient names established to minimize the differences in the nomenclature recognized by regulatory authorities in the United States and the European Union (EU) and Japan. The following discussion is included for reference. Readers should also consult applicable national laws and regulations to ensure the INCI names used for labeling are appropriate for their intended markets. The types of ingredients most frequently affected by differing regulatory approaches are:
Colorants
Botanicals (Plant-Derived Ingredients)
Denatured Alcohols
U.S. Over-the-Counter (OTC) Drug Ingredients
Trivial Names
Fragrances/Parfum
Flavors/Aromas
Labeling names for ingredients in the above categories intended for sale in the United States may be different from those intended for sale in the European Union, Japan, or in other countries. Additional information on the labeling requirements for products marketed in the United States may be found in the Council’s Labeling Manual. Information on the regulatory status of colorants in the United States and many other countries may be found in the Council’s International Color Handbook, Fourth Edition (2007). A reference guide to the cosmetic laws, regulations, and information sources for many countries may be found in the International Regulatory/Resource Manual, Sixth Edition (2007). The Council’s online data bases are also excellent sources of comprehensive information: InfoBase, and the IRDB.
The term “color additive” is defined, in part, by U.S. law 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 intermediate 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 substances) of imparting color thereto. Federal Food, Drug, and Cosmetic Act, (FD&C Act) Section 201(t)(1).
In the United States, a cosmetic containing a colorant (except a coal-tar hair dye) that is not approved by the FDA is regarded as “adulterated” and subject to regulatory action by FDA. Federal Food, Drug, and Cosmetic Act, Section 601(e).
NOTE -An exception to this requirement exists for “coal-tar” (synthetic organic) colorants used in hair dyes, provided other regulatory requirements are met (see information in this section under U.S. Hair Colorants and the U.S. Hair Dye Exemption).
U.S. Color Additives approved for use in the United States are listed in Title 21 of the U.S. Code of Federal Regulations, 21 CFR, Parts 73, and 74.
A listing of the INCI names of U.S.-approved colorants may be found in the Dictionary, under Chemical Classes, listed under the following headings:
• ColorAdditives -Batch Certified by the U.S. Food and Drug Administration
• ColorAdditive Lakes -Batch Certified by the U.S. Food and Drug Administration
• ColorAdditives -Exempt from Batch Certification by the U.S. Food and Drug Administration
Color Additives Subject to Batch Certification
With the exception of “coal-tar” hair dyes, all “synthetic organic” color additives are subject to batch certification by the FDA. Each batch of an approved synthetic organic colorant must be tested and certified by the FDA as meeting standards and specifications found in 21 CFR 74.
Color Additives Exempt from Batch Certification
Some U.S.-approved colorants are exempt from batch certification by the FDA. In order to be legally used in the U.S., however, these colorants must meet specification and use restrictions stipulated in 21 CFR 73.
Abbreviated Labeling Names for U.S. Colorants
Official names for colorants subject to batch certification may be found in the listing of the color additive in 21 CFR Parts 74, and 82. These names must be used by the colorant manufacturer to identify the color additive product (or raw material) that has been batch certified by the FDA. As discussed below, FDA currently does not object to abbreviated labeling for declaring the presence of certified batches of color additives in cosmetics. See http://www.fda.gov/cosmetics/cosmeticlabelinglabelclaims/industryrequestsfdaresponses/ucm075074.htm.
FDA originally proposed the use of abbreviated names for U.S. colorants in the Federal Register on June 6, 1985 (50 FR 23815). At that time, the FDA stated that firms may use the abbreviated names on product labels. By correspondence, dated June 7, 1999, the FDA reaffirmed its intention to permit cosmetic firms to use the abbreviated names on product labels while a final rule on the matter is pending. The abbreviated labeling names apply only to U.S. color additives that are subject to batch certification. Under this scheme, the cosmetic product manufacturer does not have to include “FD&C” or “D&C,” “No.,” or the type of lake “Aluminum, Zirconium, etc.,” on their product labels. However, for color additive lakes, the term “Lake” must be included in the declaration. Examples of the abbreviated and the original names associated with U.S. colorants are:
Blue 1 or FD&C Blue No. 1
Red 6 or D&C Red No. 6
Ext. Violet 2 or Ext. D&C Violet No. 2
Red 40 Lake or FD&C Red No. 40 Aluminum Lake
Other Restrictions for U.S. Color Additives
There may be specific use restrictions for some U.S. approved colorants, such as: “for external use except eye area.” Restrictions for U.S. approved colorants may be found in 21 CFR 73, and 74.
Proposed Use of CI Numbers for Labeling Color Additives in the U.S.
The Council has asked the U.S. FDA to recognize the advantages of allowing the use of Colour Index or CI numbers for labeling color additives on cosmetic products in the U.S. We believe that this would provide greater transparency in labeling and better value comparison under the U.S. FPLA. Current FDA policy specifies the listing of the appropriate U.S. name first, followed by the related CI number in parentheses. Users are instructed to use the formal or abbreviated nomenclature identified in the Dictionary for labeling color additives in the U.S. Prior to labeling changes, the user is encouraged to contact the Council for the most recent information on this issue. For additional information, see
http://www.fda.gov/cosmetics/cosmeticlabelinglabelclaims/industryrequestsfdaresponses/ucm075032.htm.
Colorants approved for use in the EU may be found in Annex IV of Regulation (EC) No. 1223/2009 of the European Parliament and the Council on Cosmetic Products. A listing of the INCI names for EU-approved colorants may be found in the Dictionary, under Chemical Classes, listed as Colorants - Approved in the EU.
Some approved EU colorants are chemically similar to those approved for the U.S.; however, their specifications and use limitations may differ. With a few exceptions, colorants are listed in Annex IV by their Colour Index numbers. The INCI labeling name for lakes and salts of EU colorants, not otherwise prohibited in Annex II or regulated by Annex V, is the same CI number as the colorant found in Annex IV, without reference to the laking agent or salt. Some EU-approved colorants are subject to use restrictions. For example, use restrictions may prohibit use of a colorant in the eye area or on mucous membranes. The use restrictions for EU-approved colorants may be found in Annex IV.
Harmonized INCI Names for Colorants for U.S. and EU Markets
Industry previously proposed that a dual declaration of colorants with both the U.S. name and the EU name be allowed on labels of those cosmetic products intended for sale in both the U.S. and EU markets. Examples of harmonized names are as follows:
• Green 3 (CI 42053)
• Ultramarines (CI 77007)
NOTE: Although the U.S. FDA has indicated a willingness to accept this approach as an interim step while it considers the question of harmonized ingredient labeling, readers are directed to consult with authorities in EU member states to verify EU acceptance.
Persons using harmonized INCI labeling names on products intended for the U.S. and EU markets must ensure that the colorants conform with regulatory requirements for the U.S. and the EU, i.e., batch certification from FDA where required, and/or EU Annex IV limitations and requirements, which may differ.
Colorants approved for use in Japan include synthetic organic colorants regulated by the Ordinance to Regulate Coal-Tar Colors Permitted for Use in Drugs, Quasi-drugs, and Cosmetics (Ministerial Ordinance No. 30 of 1966 as amended by MHLW Ordinance No. 126 of 2003). A listing of the INCI names of Japan-approved colorants may be found in Section 12 of the Dictionary, the Japan Index (Coal Tar Colors Permitted for Use in Cosmetics).
While many of these colorants approved for use in Japan are chemically similar to those allowed for use in the U.S. and the EU, their specifications and use restrictions may differ. The INCI names for each type of Japan colorant, the straight colorant and each metal salt or lake of a straight colorant (e.g., sodium, potassium, calcium, barium, including the lakes) are assigned a different Japan colorant name. This is in contrast to EU colorants where the Colour Index Number includes the straight colorant and its salts or lakes. The U.S. colorant INCI names identify the straight colorant and its lakes by separate names, e.g., Red 22 for the straight color and the lake as Red 22 Lake without identification of the type of lake. These differences must be noted when attempting to correlate colorants approved in Japan with those in the EU and the U.S. To assure proper identification of the colorants, the individual monographs of each colorant should be consulted along with the Colorant Cross Index Section of the Dictionary.
U.S. laws and regulations prohibit any cosmetic product intended for sale and distribution in the U.S. from containing a colorant that has not been previously approved by the FDA. An exception to this prohibition exists for “coal-tar” (synthetic organic) hair dyes in products whose labels display the following statement:
“Caution - This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing eyelashes or eyebrows; to do so may cause blindness.” Federal Food, Drug, and Cosmetic Act, Section 601(a).
In addition to the above caution statement, the labeling must include adequate directions for conducting the “preliminary test.” The term “hair dye” specifically does not include eyelash or eyebrow dyes. Federal FD&C Act, Section 601(a).
“Coal-tar” is a historical term used in U.S. regulations that relates most synthetic organic chemicals to their original coal source. Today most of these colorants are synthesized from chemicals derived from petroleum sources. “Coal-tar” dyes do not include colorants derived from vegetable substances or metallic salts, such as henna, lead acetate, and bismuth citrate. Such ingredients do not fall under the “coal-tar” hair dye exemption under U.S. Regulations (U.S. 38 Federal Register 2996, January 1, 1973). The use of vegetable substances and metallic salts require FDA approval before use as a colorant for hair.
In the U.S., INCI names for botanicals often include a parenthetical English common name after the scientific name. The reason for the inclusion of the common name originates with the intent of the U.S. FPLA (Fair Packaging and Labeling Act) which calls for the usage of terms that are recognizable to the consumer. The parenthetical English common name is omitted for the labeling of INCI names in the EU. The following discussion is included to clarify the evolution of botanical names in INCI nomenclature.
INCI names for plants, fungi and algae are based on the Linnaean binomial system which uses a scientific genus and species name to identify an organism and its place in the biological taxonomy of life. Scientific names of wild botanical species are ruled by the International Code of Nomenclature for Algae, Fungi, and Plants, and cultivated plants are covered under the International Code of Nomenclature for Cultivated Plants. Scientific names have often been called Latin names, but the origin of the words in the name can be Greek as well as modern languages.
There are notable differences between INCI names and scientific names. The special punctuation, formatting, and rules called for in the taxonomic codes for scientific names are not utilized in INCI nomenclature in order to facilitate the ease of creating finished product labels for cosmetic products. For example, the scientific codes call for the scientific genus and species term to appear in italics, with the genus term capitalized and the species name in lower case (e.g., Cocos nucifera). In the biological nomenclatures, species can be split into varieties or subspecies, which is indicated by the abbreviation "var." or "ssp. / subsp." before the variety or subspecies name. Hybrids resulting from the cross-breeding between species are identified by the symbol “´” between each parent species name or before a special hybrid epithet (e.g., Mentha x piperita). Particular types of cultivated plants are indicated with group names, cultivar names, patent names, or trademark names, which not always are reflected in the INCI name (e.g., Brassica oleracea Italica Group).
Another departure from the scientific binomial system is the inclusion of the English common name in parentheses for many INCI names. Originally, the INCI names for plants were designated by their English common name. During the 1990s when the change was made to follow the Linnaean system, it was decided to retain the English common name in parentheses in order to harmonize the original names with the new science-based names (e.g., Cocos Nucifera (Coconut) Oil). As a matter of practice, the parenthetical term is only included for plants in the INCI system that already had the common name included. Further distinction is the inclusion of plant parts in INCI names (Bambusa Vulgaris Leaf/Stem Extract), and the use of slash marks to separate multiple plant parts, neither of which is indicated in the scientific names, which applies to the organism as a whole. The INCI conventions for botanicals are fully described in the Conventions Section.
Due to the dynamic nature of evolutionary plant classification and research, the scientific nomenclature for plants is continually being updated based on new research results. With the advent of new DNA-based and computer-assisted methods, species relationships can now be investigated in more detail, and the results have shown that many traditional scientific names need to be changed since some plants were not previously classified into natural, evolutionary groups. In cases where the species has to be placed in a different genus, the genus name changes, and sometimes the species name changes (e.g., from Butyrospermum parkii to Vitellaria paradoxa). If two species are merged, the younger name becomes a synonym. This has also led to the reclassifying and recircumscription of some families, which in the long run will lead to a more stable system of scientific names, and ultimately related INCI names.
“Alcohol Denat.” is the established INCI labeling name for ethyl alcohol that is denatured (rendered non-potable) in accordance with national regulations in the EU member states and in the United States.
In the United States, the names and formula specifications for specially denatured (SD) alcohols, e.g., SD Alcohol 40-D, are listed in the U.S. Department of the Treasury Regulations under Title 27, U.S. Code of Federal Regulations, Parts 20 and 21 (27 CFR 20 and 21). The monographs for the SD alcohols provide information on the denaturants required to be used in the United States.
For the U.S. market, labelers may use either the specific “SD Alcohol” names or “Alcohol Denat.” on product labels, however the regulations codified in 27 CFR Parts 20 and 21 must be followed. For products intended to be marketed in the United States and the EU, the name “Alcohol Denat.” should be used.
Many countries have regulatory requirements for cosmetics that are different from products that may function as drugs or have medicinal properties. Frequently, countries also define cosmetic and drug functions differently. The reader is directed to consult the laws and regulations of the region where a product is intended for market to ensure compliance.
In general, a substance or product that is intended to significantly affect the structure or function of the body, or to treat or cure disease is regulated as a drug. In contrast, a substance or a product that is intended to cleanse, promote attractiveness, or temporarily alter the appearance of the body is regulated as a cosmetic. In the U.S., the intended function for an ingredient or finished product is determined on the basis of claims made by the finished product manufacturer; the claims or other representations made for a product ultimately determine its classification and how it is regulated. The reader is directed to consult the Personal Care Products Council Labeling Manual, 9th edition, 2013, for further information.
Some functions for ingredients listed in the Dictionary, may cause products containing them to be subject to drug, quasi-drug, “functional,” or other regulations in addition to the basic regulations required for cosmetics. Examples of such functions in the U.S. are the OTC drug functions published in the Dictionary: antiacne, anticaries, antidandruff, antifungals, antimicrobials, antiperspirants, corn/callus/wart removers, drug astringents, oral healthcare drugs, skin protectants, external analgesics, skin bleaching agents, skin protectants, and sunscreens. Furthermore, based on labeling claims, a product may be subject to both the cosmetic and drug regulations in some countries.
The regulatory approach dealing with the distinction of a cosmetic from a drug varies from country to country. In the U.S., Over-the Counter (OTC) drug ingredients are regulated by the FDA under regulations associated with the U.S. OTC Drug Review Process. Products that comply with the final OTC monograph and other general FDA requirements may be marketed as an OTC drug product without specific FDA pre-market approval of a New Drug Application (NDA). The reader is directed to consult the appropriate OTC drug monograph for drug usage requirements.
Some U.S. OTC active drug ingredients have been reported to have a purely cosmetic purpose in cosmetic formulations, in addition to being safe and effective drug ingredients. Also, some U.S. OTC drug functions may be regulated as cosmetics in other countries. Such functions may therefore be identified for ingredients that are not described as safe and effective by the U.S. OTC Drug Review Process. The Dictionary distinguishes U.S. OTC Category I active drug ingredients in the following manner: an ingredient’s monograph definition in Section 1 of the Dictionary references the approved U.S. OTC drug usage, along with referencing the OTC category in the Information Sources field of the monograph; Section 3, Functions of the Dictionary, identifies with an asterisk those ingredients approved for use as U.S. Category I active drug ingredients. Finally, when the U.S. drug name differs from the INCI name, a notation is included in both Section 1 and Section 3.
In the EU, labeling claims, areas of application, and the purposes of their application define how the product will be regarded by Regulation. Regulation (EC) No. 1223/2009 contains a series of Annexes setting out the lists of substances subject to prohibitions as well as substances that are subject to restrictions or are provisionally allowed. The preamble of the EU Cosmetics Regulation identifies products that belong to the cosmetic category. Medicinal products are regulated in the EU by Directive 2004/27/EC. In Japan, cosmetics are regulated by the Ministry of Health, Labor, and Welfare (MHLW) under the Pharmaceutical Affairs Law and the amended Enforcement Regulations of the Pharmaceutical Law of 2001. Japan has a similar cosmetic and drug distinction as in the U.S. and the EU. In addition, it has a category of products referred to as “quasi-drugs” that by definition have a mild effect on the human body.
Many other countries follow the regulations of the EU, Japan, or the U.S. for selected requirements. Users of the Dictionary must consult the regulatory requirements of the country in which they intend to market their products. Sources of additional information for regulatory requirements may be found in the Council’s International Regulatory Resource Manual, International Color Handbook, Labeling Manual, and also in the Council’s subscription data bases, International Regulatory Data Base (IRDB) and the InfoBase.
EU Trivial Names
The Dictionary contains some EU “trivial” names, or common names that should be easily recognized by consumers in the EU where twenty-two different languages are spoken. The trivial names are based primarily on designations taken from the European Pharmacopoeia. EU regulations specify that the trivial names must be used for ingredient labeling. For a complete listing of these names, key in (EU) in the ingredient search field of the INCI data base. Examples of INCI labeling names harmonized for the U.S. and EU markets are shown below:
Water (Aqua)
Beeswax (Cera Alba)
Sea Salt (Maris Sal)
EU Trivial Names and Canada
In Canada, INCI ingredient labeling requirements only apply to cosmetic products; INCI nomenclature is acceptable for drugs and natural health products for listing non-medicinal ingredients. A list of ingredients, using INCI names, must appear on the outer label of a cosmetic. An ingredient that has no INCI name must be listed by its chemical name. The label must be legible and follow all other labeling requirements of the Canadian Cosmetic Regulations and the Consumer Packaging and Labeling Act.
In addition to names, if an ingredient is listed in the schedule of Subsection 21.2(4) of the Act, it may be listed either by its EU trivial name in column 1 of the schedule or by the appropriate English and French equivalents set out in columns 2 and 3. There are 57 such designations. For example, the EU trivial name Canola could be listed, or Canola Oil/Huile de colza could be listed. Also, Aqua or Water/Eau. For additional information see Health Canada website at http://www.hc-sc.gc.ca.
Japan Trivial Names
The Dictionary also contains some Japanese “trivial” names, names that have traditional meaning for Japanese consumers. Many of these ingredients may be derived from multiple sources, and thus may refer to more than one INCI name. For example, the trivial name Orange Yu is defined as the essential oil obtained from the peel of the fruit of Citrus spp. As such, this Japanese trivial name may correspond to several INCI names including Citrus Aurantium Dulcis (Orange) Oil, Citrus Aurantium Amara (Bitter Orange) Oil, Citrus Grandis (Grapefruit) Peel Oil.
Additionally, some Japanese “trivial” names listed in the Japanese Cosmetic Licensing Standard relate to ingredients which are not associated with an INCI name, e.g., Aloe Yohjyu Matsu Ekisu. For a complete listing of Japanese trivial names, key in (JPN) in the ingredient search field of the INCI database.
The terms Fragrance and Parfum are used as INCI labeling names in the U.S. and the EU, respectively, and other global regions. These names are used to identify that a product contains a material or combination of materials to produce or to mask a particular odor.
In the EU, specific fragrance materials identified in Annex III to Regulation (EC) No 1223/2009 must be individually labeled if they are present in the formulation at concentrations greater than 0.001% in leave-on products or greater than 0.01% in rinse-off products. This applies regardless of the source or function of these ingredients. A complete list of these materials is described below by INCI name. Note, several entries on Annex III published in 2023 are identified by Group Names. The Group Names have been monographed as INCI Names. These names are indicated below in boldface followed by the related INCI names and must be used for the ingredient labeling of these materials for products marketed in the EU.
3-Propylidenephthalide
6-Methyl Coumarin
Acetyl Cedrene
Alpha-Isomethyl Ionone
Alpha-Terpinene
Amyl Cinnamal
Amyl Salicylate
Amylcinnamyl Alcohol
Anethole
Anise Alcohol
Benzaldehyde
Benzyl Alcohol
Benzyl Benzoate
Benzyl Cinnamate
Benzyl Salicylate
Beta-Caryophyllene
Butylphenyl Methylpropional
Camphor
Cananga Odorata Oil/Extract
Cananga Odorata Flower Extract
Cananga Odorata Flower Oil
Carvone
Cedrus Atlantica Oil/Extract
Cedrus Atlantica Bark Extract
Cedrus Atlantica Bark Oil
Cedrus Atlantica Bark Water
Cedrus Atlantica Leaf Extract
Cedrus Atlantica Wood Extract
Cedrus Atlantica Wood Oil
Cinnamal
Cinnamomum Cassia Leaf Oil
Cinnamomum Zeylanicum Bark Oil
Cinnamyl Alcohol
Citral
Citronellol
Citrus Aurantium Bergamia (Bergamot) Peel Oil
Citrus Aurantium Flower Oil
Citrus Aurantium Amara (Bitter Orange) Flower Oil
Citrus Aurantium Dulcis (Orange) Flower Oil
Citrus Aurantium Peel Oil
Citrus Aurantium Amara (Bitter Orange) Peel Oil
Citrus Aurantium Dulcis (Orange) Peel Oil
Citrus Sinensis (Orange) Peel Oil
Citrus Limon (Lemon) Peel Oil
Coumarin
Dimethyl Phenethyl Acetate
Eucalyptus Globulus Oil
Eucalyptus Globulus Leaf Oil
Eucalyptus Globulus Leaf/Twig Oil
Eucalyptus Oil
Eugenia Caryophyllus Oil
Eugenia Caryophyllus (Clove) Bud Oil
Eugenia Caryophyllus (Clove) Flower Oil
Eugenia Caryophyllus (Clove) Leaf Oil
Eugenia Caryophyllus (Clove) Stem Oil
Eugenol
Eugenyl Acetate
Evernia Furfuracea (Treemoss) Extract
Evernia Prunastri (Oakmoss) Extract
Farnesol
Geraniol
Geranyl Acetate
Hexadecanolactone
Hexamethylindanopyran
Hexyl Cinnamal
Hydroxycitronellal
Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde
Isoeugenol
Isoeugenyl Acetate
Jasmine Oil/Extract
Jasminum Grandiflorum (Jasmine) Flower Extract
Jasminum Grandiflorum (Jasmine) Flower Oil
Jasminum Officinale (Jasmine) Flower Extract
Jasminum Officinale (Jasmine) Extract
Jasminum Officinale (Jasmine) Oil
Juniperus Virginiana Oil
Juniperus Virginiana Wood Oil
Laurus Nobilis Leaf Oil
Lavandula Oil/Extract
Lavandula Angustifolia (Lavender) Flower Extract
Lavandula Angustifolia (Lavender) Flower Oil
Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract
Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Juice
Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Oil
Lavandula Angustifolia (Lavender) Oil
Lavandula Hybrida Extract
Lavandula Hybrida Flower Extract
Lavandula Hybrida Oil
Lavandula Intermedia Flower/Leaf/Stem Extract
Lavandula Intermedia Flower/Leaf/Stem Oil
Lavandula Intermedia Oil
Lemongrass Oil
Cymbopogon Citratus Leaf Oil
Cymbopogon Citratus Leaf/Stem Oil
Cymbopogon Flexuosus Leaf Oil
Cymbopogon Flexuosus Leaf/Stem Oil
Cymbopogon Flexuosus Oil
Cymbopogon Schoenanthus Oil
Limonene
Linalool
Linalyl Acetate
Lippia Citriodora Absolute
Lippia Citrodora Flower Extract
Lippia Citrodora Flower/Leaf/Stem Extract
Lippia Citrodora Leaf Extract
Mentha Piperita (Peppermint) Oil
Mentha Spicata Flower/Leaf/Stem Oil
Mentha Spicata Leaf/Stem Oil
Mentha Viridis (Spearmint) Leaf Oil
Menthol
Methyl 2-Octynoate
Methyl Salicylate
Myroxylon Pereirae Oil/Extract
Myroxylon Pereirae (Balsam Peru) Oil
Myroxylon Pereirae (Balsam Peru) Resin
Myroxylon Pereirae (Balsam Peru) Resin Extract
Narcissus Extract
Narcissus Jonquilla Extract
Narcissus Poeticus Extract
Narcissus Pseudonarcissus (Daffodil) Flower Extract
Narcissus Tazetta Extract
Pelargonium Graveolens Flower Oil
Pinene
Pinus Mugo
Pinus Mugo Leaf Oil
Pinus Mugo Leaf/Twig Extract
Pinus Mugo Twig Oil
Pinus Pumilio Branch/Leaf Oil
Pinus Pumilio Leaf Extract
Pinus Pumila
Pinus Pumila Leaf/Twig Extract
Pinus Pumila Leaf/Twig Oil
Pinus Pumila Needle Extract
Pogostemon Cablin Oil
Rose Flower Oil/Extract
Rosa Alba Flower Extract
Rosa Alba Flower Oil
Rosa Canina Flower Oil
Rosa Centifolia Flower Extract
Rosa Centifolia Flower Oil
Rosa Damascena Flower Extract
Rosa Damascena Flower Oil
Rosa Gallica Flower Extract
Rosa Gallica Flower Oil
Rosa Hybrid Flower Extract
Rosa Moschata Flower Oil
Rosa Moschata Oil
Rosa Rugosa Flower Oil
Rose Flower Oil
Rose Ketones
Alpha-Damascone
Delta-Damascone
Salicylaldehyde
Santalol
Santalum Album (Sandalwood) Oil
Sclareol
Terpineol
Terpinolene
Tetramethyl Acetyloctahydronaphthalenes
Trimethylbenzenepropanol
Trimethylcyclopentenyl Methylisopentenol
Turpentine
Vanillin
The terms Flavor and Aroma are used as INCI labeling names in the United States and the EU, respectively. These names are used to identify that a product contains a material or combination of materials to produce or to mask a particular flavor.
The Minamata Convention on Mercury, which went into effect on January 19, 2013, is a global treaty to protect human health and the environment from the adverse effects of mercury. Consistent with the provisions of the treaty, and by petition from the U.S. Food and Drug Administration, mercuric oxide has been removed from the Dictionary. Soaps and cosmetics containing more than 1 part per million of mercury will be banned by 2020. Eye-area cosmetics are exempt because of concerns that there are no effective and safe substitute preservatives available for these product-types. Respective monographs in the Dictionary have been referenced to Minimata in the Information Sources field.
The ingredients in the Dictionary do not represent an approved list of cosmetic ingredients. The inclusion of any ingredient means only that it is offered for sale for use in cosmetic products. It does not imply that the substance is safe for use as a cosmetic ingredient, nor does it indicate that its use as a cosmetic ingredient complies with the laws and regulations of the United States or any other country.
The assignment of an INCI name does not imply that the ingredient is “approved,” “certified,” or “endorsed” by the Council or any other organization or governmental body. Conversely, the absence of an ingredient from the Dictionary does not imply that the ingredient may not or should not be used in finished cosmetic products. INCI names do not imply standards or grades of purity.
NOTE: The suitability for use of any ingredient, as a component of a finished cosmetic product or for any other purpose, is solely the responsibility of the cosmetic product manufacturer, the distributor, or other users of this publication.
Manufacturers intending to produce and/or market cosmetic products in the United States are urged to consult applicable regulations. These regulations may be found in the U.S. Code of Federal Regulations, Title 21 (21 CFR). Manufacturers are also urged to check notices in the U.S. Federal Register and to familiarize themselves with state laws and regulations that may provide additional information regarding the manufacture and sale of cosmetic products.
Firms marketing products in countries outside the United States should consult the laws and regulations in those countries for information on their legal requirements. For information on the laws and regulations of many countries, see the latest edition of the International Regulatory/Resource Manual, or consult the International Cosmetic Legal and Regulatory Database, http://irdb.personalcarecouncil.org/,both available from the Council.
The identification of a function in a monograph should not be construed as proof that the ingredient performs such function in a finished cosmetic product. The function of an ingredient is often affected by other ingredients in the formulation. Functions listed for ingredients are identified by the supplier or provided by users of this publication.
The INCI names in the Dictionary are recognized by the U.S. Food and Drug Administration as the labeling names that must be used for cosmetic ingredient labeling under U.S. regulation 21 CFR 701.3. This recognition of the Dictionary does not imply that the ingredients contained therein are considered to be “safe” or “approved” for use by the FDA.
INCI names are associated with CAS and EC numbers where possible.
CAS Registry Numbers are assigned by the Chemical Abstracts Service (CAS) to a given chemical substance. CAS Registry Numbers serve to index worldwide literature for chemical substances. CAS Registry Numbers are also assigned for reporting purposes under the U.S. Environmental Protection Agency’s Toxic Substances Control Act (TSCA) and serve as identifiers for the registration of substances in various global jurisdictions.
EC Registry Numbers are 7-digit numbers that relate to substances registered under REACH by ECHA.
The relationship between a registry number and an INCI name is not always one-to-one. In some cases, more than one INCI name may have the same CAS number, or more than one CAS number may apply to an INCI name. For example, polymers may share a CAS number that is generic to variable chain lengths of a common monomer mixture. Alternatively, CAS numbers for specific stereoisomers in most cases will be related to a single INCI name. For further information about CAS numbers, please consult the CAS website: https://www.cas.org/.
The functions for an ingredient listed in the Dictionary are primarily those that are provided by the supplier and are classified on the basis of the function an ingredient may perform in a finished product. Many ingredients have multiple functions in formulation and therefore are included in several functional groupings. The definition of each function listed in the Dictionary is provided in the specific cross-reference section, Reported Functions. Ultimately, the suitability and intended use of an ingredient is the responsibility of the marketing company. Users interested in updating the function(s) for an ingredient should contact the Personal Care Products Council.
The use of an ingredient for a function other than those listed in the Dictionary may be acceptable. The inclusion of an ingredient under a given function in the Dictionary does not imply that the ingredient is “approved,” “certified,” or “endorsed” for that use by the Personal Care Products Council or any other organization or governmental body in the U.S., the EU, Japan, or any other country.
The monographs for INCI names contain an information field that identifies the source(s) of the ingredient. These sources are:
· Animal
· Plant
· Mineral
· Synthetic
· Bacteria, Fungi, or other Single-Celled Organism
The selection of source(s) for cosmetic ingredients is based, in general, on the following criteria:
1. The source of an ingredient is determined from information found in the definition of the ingredient contained in each monograph or based on information provided by the supplier of the ingredient. In some cases, the source information is obtained from the Merck Index or other compendia.
2. All hydrocarbons and other substances derived from coal, coal tar, or refined from “crude oil” extracted from the earth are identified as synthetic.
3. Where the source of an ingredient is identified as animal, the type of animal is not identified.
4. The source for botanical ingredients is identified as plant.
5. Extracts are identified by the source of the material extracted.
6. Hydrolysates are identified by the source of the material hydrolyzed.
7. One or more sources may apply to a given INCI name when that material may be derived from more than one source. Different trade materials related to an INCI name may be obtained from different sources.
8. Synthetic is assigned as a source for ingredients that are prepared (“synthesized”) by the reaction of a substance with one or more other substances to form a new chemical entity.
9. In cases when it is very clear that a raw material used to synthesize an ingredient is plant or animal derived, that source may be listed. For example, animal and synthetic are both listed as sources for Lanolinamidopropyl Betaine to indicate that one of the starting materials is derived from an animal source, in this case lanolin, and that the material is derived by a synthetic process. Similarly, plant and synthetic are both listed as sources for Soyamide DEA to indicate that the starting materials are derived from a plant source and a synthetic one.
10. If a supplier of an ingredient has information to document that an ingredient is obtained from a source different than the one(s) listed in the monograph, they may submit this information for consideration to the INC.
Additional sources for raw materials not cited in the monograph are possible, e.g., ingredients derived through microbial processes. Moreover, newer sources may be possible for ingredients traditionally made available through synthetic processes. It is not the intent of this publication to identify all possible sources for raw materials.
The product categories and frequency of use data for an ingredient listed in the Dictionary are derived from FDA's Voluntary Cosmetic Registration Program (VCRP). The VCRP is a voluntary reporting system for cosmetic and personal care products that are in commercial distribution in the United States.
Names identified in an INCI monograph as “VCRP Reported Name” may include terms other than the INCI name because the information is obtained “as reported” by the manufacturer. The VCRP data is updated annually by PCPC for inclusion in the Dictionary. The VCRP regulations can be found in 21 CFR, parts 710 and 720.
The FDA VCRP is not a premarket approval program. The safety, suitability and intended use of an ingredient in a product category is the responsibility of the marketing company. The listing of an ingredient in a product category in the Dictionary or noted as a VCRP reported ingredient does not imply that the ingredient is “approved,” “certified,” or “endorsed” for that use by the Personal Care Products Council or any other organization or governmental body in the U.S., the EU, Japan, or any other country.
The term “(and)” - The term “(and)” in the INCI name assignment for trade name mixtures is used between individual ingredients to identify the components of the blends. When labeling a finished product containing a trade name material that is a mixture or blend, each component of the mixture is to be listed in descending order of predominance with respect to all ingredients in theformulation. The term “(and)” should not be used when listing the ingredients on the finished product label. Information on the actual concentration of each component of such mixtures should be obtained from the supplier.
Solvents and Diluents - Solvents and diluents in raw materials, such as surfactants, polymers, and resins, are not always identified as part of the INCI name. However, diluents and/or solvents must be listed on the finished product package label in their proper order of predominance with respect to all other ingredients in the formulation. Information on the concentration of solvents and/or diluents contained in such raw materials should be obtained by the marketing company from the supplier.
Extracts - The INCI names for extracts represent the “material extracted”. Many extracts are supplied with the extracting solvent and/or other diluents. The solvents and/or diluents in extracts must be listed in their proper order of predominance, along with all other ingredients in the formulation, on the package label. Information on the concentration of solvents and/or diluents in a specific extract must be obtained by the marketing company from the supplier.
Incidental Ingredients - Incidental ingredients include antioxidants, preservatives, or processing aids that are present for a specific function in a raw material but are not intended to have a technical or functional effect in the finished cosmetic and are typically present at an insignificant level in the finished cosmetic product. Incidental ingredients contained in cosmetic raw materials are often not included in the INCI name. Because some jurisdictions may require that incidental ingredients be included in product information files, finished product manufacturers should work with their ingredient suppliers to ensure the completeness of their product listings. For more information on requirements for incidental ingredients in the U.S., see 21 CFR 701.3 (l)(1) and (2).
Additional information on the labeling requirements for products marketed in the United States may be found in the Council’s Labeling Manual. Information on the regulatory status of colorants in the United States and many other countries may be found in the Council’s International Color Handbook, Fourth Edition (2007). A reference guide to the cosmetic laws, regulations, and information sources for many countries may be found in the International Regulatory/Resource Manual, Sixth Edition (2007). The Council’s online data bases are also excellent sources of comprehensive information: InfoBase, and the IRDB.