COMMISSION DECISION of 8 May 1996 establishing an inventory and a common nomenclature of ingredients employed in cosmetic products (Text with EEA relevance) (96/335/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

having regard to the Treaty establishing the European Community,

Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (), as amended by Commission Directive 95/34/EC (), and in particular Article 5a and Article 7(2) thereof,

After consultation of the Scientific Committee on Cosmetology,

Whereas the inventory of ingredients used in cosmetic products must include a section on perfume and aromatic raw materials and a section on other substances;

Whereas this inventory must contain information on the identity of each ingredient, notably the chemical, INCI (ex-CTFA), Ph. Eur., INN and Iupac names, the Einecs/ Elincs, CAS and Colour Index numbers, the common name referred to in Article 7 (2) of Directive 76/768/EEC, as well as the ingredient's functions and, where appropriate, any restrictions and conditions of use and warnings which must be printed on the label;

Whereas, in addition to providing necessary information on the ingredients used in cosmetic products, the inventory must be seen in the context of the obligation laid down by Article 6 (1) of Directive 76/768/EEC, which stipulates indication on the product and/or packaging of the function of the product and the list of ingredients as of 1 January 1997 in the case of cosmetic products placed on the market;

Whereas the proposed inventory must be sufficiently complete to allow the labelling of ingredients for cosmetic products;

Whereas it shall, however, be indicative and shall not constitute a list of substances authorized for use in cosmetic products;

Whereas it must be periodically updated;

Whereas a common ingredients nomenclature will make it possible to identify the substances by using a single name in all the Member States, with the result that consumers will easily be able to recognize substances which they have been advised to avoid (for example because of allergies), no matter where they buy cosmetic products in the Community;

Whereas the INCI (International Nomenclature Cosmetic Ingredient) names best meet these requirements, being relatively simple and, moreover, already in use at international level;

Whereas the measures provided for in this Decision are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Cosmetic Products Sector;

DECIDES:

Article 1

The inventory of ingredients used in cosmetic products provided for in Article 5a of Directive 76/768/EEC and reproduced in the Annex is adopted.

Article 2

The INCI (International Nomenclature Cosmetic Ingredient) names contained in the inventory shall constitute the common nomenclature for the purposes of Article 7 (2) of Directive 76/768/EEC.

Done in Brussels, 8 May 1996.

For the Commission

Emma BONINO

Member of the Commission

() OJ No L 262, 27. 9. 1976, p. 169.

() OJ No L 167, 18. 7. 1995, p. 19.

ANNEX

INVENTORY OF COSMETIC INGREDIENTS

GENERAL INTRODUCTION

1. Council Directive 93/35/EEC of 14 June 1993 amending for the sixth time Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products () (hereafter called 'cosmetic products Directive') provides that the Commission shall, under the procedure involving the Committee on Adaptation to Technical Progress referred to in Article 10 of Directive 76/768/EEC, compile an inventory of ingredients employed in cosmetic products, on the basis in particular of information supplied by the industry concerned. The inventory shall be indicative and shall not constitute a list of substances authorized for use in cosmetic products.

The inventory must be divided into two sections concerning:

- perfume and aromatic raw materials,

- other substances.

The inventory must contain information concerning the identity of the ingredient, notably: the INCI (ex CFTA), Ph. Eur., INN, Iupac and chemical names, the Einecs/Elincs, CAS and Colour Index numbers, the common name referred to in Article 7 (2) of the amended Directive 76/768/EEC, as well as the ingredient's functions and any mandatory restrictions, conditions of use and warnings.

In addition to the relevance of having information on the ingredients used in cosmetic products, whose safety has to be guaranteed, the inventory must be seen in the context of the obligation laid down by the new Article 6 (1) (Article 1 (7) of Directive 93/35/EEC) which makes it mandatory to indicate on the product and/or packaging (for the list) the function of the product and the list of ingredients as of 1 January 1997 for cosmetic products placed on the market.

Directive 93/35/EEC also provides that Member States may require that the ingredients be indicated in a language easily understood by the consumer and that to this end the Commission must adopt a common ingredients nomenclature in accordance with the CATP procedure (Article 1 (10) of Directive 93/35/EEC amending Article 7 (2) of Directive 76/768/EEC).

This common nomenclature will make it possible to identify the substances by using a unique name in all the Member States with the result that consumers will easily be able to recognize substances which they have been advised to avoid (for example because of allergies), no matter where they buy cosmetic products in the European Union.

Pursuant to Commission Decision of ..., all the INCI names constitute the common nomenclature.

2. The inventory proposed by the Commission includes the two sections provided for in Directive 93/35/EEC, namely:

- a list of cosmetic ingredients other than perfume and aromatic raw materials (Section 1),

and

- a list of perfume and aromatic raw materials (Section 2).

The proposed inventory is the best that could be achieved in the very short time limits imposed by Directive 93/35/EEC. The aim was that it should be sufficiently complete to permit cosmetic products to be labelled and also as correct and detailed as possible.

However, Article 1 (4) (3) of Directive 93/35/EEC specifies that the inventory must be periodically updated.

SECTION I

COSMETIC INGREDIENTS OTHER THAN PERFUME AND AROMATIC RAW MATERIALS

Introduction

This list has been prepared in particular on the basis of information provided by the European Cosmetic Industry represented by the European Cosmetic Toiletry and Perfumery Association (Colipa).

The list covers all items foreseen under Article 5a of the cosmetic products Directive concerning identity, usual function(s), and restrictions on cosmetic ingredients. The ingredients are listed in the alphabetical order of the INCI names, which constitute together the common nomenclature for labelling throughout the EU.

The following fields are included:

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The listed functions are defined as follows:

ABRASIVES

Substances which are added to cosmetic products either to remove materials from various body surfaces or to aid mechanical tooth cleaning or to improve gloss.

ABSORBENTS

Substances which are added to cosmetic products to take up water- and/or oil- soluble dissolved or finely dispersed substances.

ADDITIVES

Substances which are added to cosmetic products, often in relatively small amounts, to impart or improve desirable properties or suppress (or minimize) undesirable properties.

ANTICORROSIVES

Substances which are added to cosmetic products to avoid corrosion of the packaging.

ANTIDANDRUFF AGENTS

Substances which are added to hair care products to control dandruff.

ANTIFOAMING AGENTS

Substances which are added to cosmetic products either to suppress foam during manufacturing or to reduce the tendency of finished products to generate foam.

ANTIMICROBIALS

Substances which are added to cosmetic-products to help reduce the activities of microorganisms on the skin or body.

ANTIOXIDANTS

Substances which are added to cosmetic products to inhibit reactions promoted by oxygen, thus avoiding oxidation and rancidity.

ANTIPERSPIRANT AGENTS

Substances which are added to cosmetic formulation to reduce perspiration.

ANTISTATIC AGENTS

Substances which are added to cosmetic products to reduce static electricity by neutralizing electrical charge on a surface.

BINDERS

Substances which are added to solid cosmetic mixtures to provide cohesion.

BIOLOGICAL ADDITIVES

Substances derived from biological origin which are added to cosmetic products to achieve specific formulation features.

BLEACHING AGENTS

Substances which are added to cosmetic products with the intention of lightening the shade of hair or skin.

BOTANICALS

Substances which are derived from plants, mostly by physical means, added to cosmetic products to achieve specific formulation features.

BUFFERING AGENTS

Substances which are added to cosmetic products to adjust or stabilize the pH thereof.

CHELATING AGENTS

Substances which are added to cosmetic products to react and to form complexes with metal ions which could affect stability and/or appearance of cosmetics.

COSMETIC COLORANTS

Substances which are added to cosmetic products to colour the cosmetic product and/or to impart colour to the skin and/or its appendages. All colours listed are substances of the positive list of colorants (Annex IV of the cosmetic products Directive).

DENATURANTS

Substances which are mostly added to cosmetic products containing ethyl alcohol, in order to render them unpalatable.

DEODORANT AGENTS

Substances added to cosmetic products to reduce or mask unpleasant body odours.

DEPILATORY AGENTS

Substances which are added to cosmetic products to remove unwanted body hair.

EMOLLIENTS

Substances which are added to cosmetic products to soften and smooth the skin.

EMULSIFYING AGENTS

Substances which are added to cosmetic products and which are surface-active agents that promote the formation of intimate mixtures of immiscible liquids.

EMULSION STABILIZERS

Substances which are added to cosmetic products to help the process of emulsification and to improve formulation stability and shelf-life.

FILM FORMERS

Substances which are added to cosmetic products to produce, upon application, a continuous film on skin, hair or nails.

HAIR DYES

Substances which are added to cosmetic products to colour hair.

HUMECTANTS

Substances which are added to cosmetic products to hold and retain moisture.

OPACIFIERS

Substances which are added to transparent or translucent cosmetic products to render them more impervious to visible light and nearby radiation.

ORAL CARE AGENTS

Substances which are added to cosmetic products for the care of the oral cavity.

OXIDIZING AGENTS

Substances which are added to cosmetic products to change the chemical nature of another substance by adding oxygen.

PRESERVATIVES

Substances which are added to cosmetic products for the primary purpose of inhibiting the development of micro-organisms therein.

PROPELLANTS

Gaseous substances added to cosmetic products under pressure in pressure-resistant containers for expelling the contents of the containers when the pressure is released.

REDUCING AGENTS

Substances added to cosmetic products which change the chemical nature of another substance by adding hydrogen or removing oxygen.

SOLVENTS

Substances which are added to cosmetic products to dissolve other components.

SURFACTANTS

Substances which are added to cosmetic products to lower the surface tension as well as to aid the even distribution of the cosmetic product, when used.

UV ABSORBERS

Substances which are added to cosmetic products specifically intended to filter certain UV rays in order to protect the skin or the products from certain harmful effects of these rays. In order to protect the skin from these effects, only the use of substances listed in Annex VII of the cosmetic products Directive is allowed.

VISCOSITY CONTROLLING AGENTS

Substances which are added to cosmetic products to increase or decrease the viscosity of the finished product.

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SECTION II

PERFUME AND AROMATIC RAW MATERIALS

1. Introduction

These lists are representative of the basic materials used in perfumes and aromatic compositions. The lists were compiled mainly on the basis of information provided by EFFA (European Flavour and Fragrance Association). They constitute the inventory of fragrance ingredients.

2. Identity of fragrance ingredients

Fragrance ingredients do not need a common nomenclature because the fragrance or their ingredients (perfume and aromatic compositions and their raw materials) must be indicated on the labels using the words 'perfume' or 'flavour' (Article 6 (1) (g) of the cosmetic products Directive). Hence the information on the identity of these substances consists of a chemical name identifying the substances in the clearest possible way. Such a system already exists in the 'acquis communautaire' - namely the Einecs inventory ('European Inventory of Existing Commercial Chemical Substances'), (Official Journal of the European Communities No C 146A of 15 June 1990) and Elincs ('European List of Notified Chemical Substances'), whose most recent version was published in Official Journal of the European Communities No C 361 of 17 December 1994. These publications mainly contain the information necessary to describe a chemical substance in an unequivocal manner, i.e. a chemical name, a CAS number and an Einecs number.

These lists also include substances of unknown structure, of variable composition or of biological origin (so-called UVCB substances). This is why the inventory of fragrance ingredients was compiled on the basis of the Einecs system. The other identifiers mentioned in Directive 93/35/EEC cannot be applied (CTFA name, European Pharmacopoeia name, names recognized by the World Health Organization, Colour Index number). The Iupac identifier is covered by the Einecs identifier.

When substances have not been included in the Einecs system, only the CAS number and CAS name have been indicated.

3. Function of fragrance ingredients

The function of all ingredients included in this inventory is to perfume. Certain ingredients however may have several functions.

Substances used in fragrances for their properties in mixtures (solvents, excipients, etc.) are also included in the list. According to Article 6 (1) (g) of the cosmetic products Directive, these substances may be considered as part of the fragrance and do not have to be declared as a cosmetic ingredient, provided they are not used in excess of the recommended levels.

4. Restrictions applicable to fragrance ingredients

Restrictions on the use of a given ingredient are identified wherever relevant. These restrictions are set out in the Directive itself or in the IFRA (International Fragrance Association) Code of Practice. These restrictions may take the form of a quantitative limitation (expressed as a percentage of the final product or as a concentration for application to the skin), or the ingredient may have to meet certain specifications or may only be used in conjunction with certain specified ingredients.

These substances are marked in the list with one asterisk (*) (IFRA restrictions) or two asterisks (**) (restrictions in the cosmetic products Directive).

5. The fragrance inventory as a representative list

It should be noted that in this inventory the various qualities of a given ingredient, such as geraniol, have not been recorded separately; the same applies to different qualities of natural products with the same botanical origin. Orange oils from Brazil, Florida, California, etc., concentrated or otherwise, are all indicated under a single entry, i.e. 'sweet orange extractives', CAS 8028-48-6, Einecs 232-433-8. This rubric is defined as follows: 'Extractives and their physically modified derivates such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc. obtained from Citrus sinensis, Rutaceae'.

Neither does the inventory include ingredients whose chemical identity is secret and constitutes the intellectual property of a fragrances manufacturer. These substances are not sold as such but used exclusively in fragrance compositions, generally at low concentrations to give them a certain characteristic and/or exclusiveness.

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NOMENCLATURE CONVENTIONS

The conventions used for establishing INCI names are as follows:

1. In order to facilitate use and clarity, INCI names have been designed to require a minimum of punctuation and capitalization.

2. Wherever new nomenclature has been adopted, every effort has been made to use the shortest name consistent with these rules.

3. Simple chemical names are used wherever possible.

4. Recognized chemical abbreviations are used where applicable. A list of the abbreviations used in the Inventory may be found on page 684.

5. Traditional stems are retained as combining forms when consistent with other systems.

6. Abbreviations are utilized for simplifying the nomenclature of families of complex ingredients when applicable.

7. Compounds that are related or are similar to materials described in recognized sources are named, whenever possible, by analogy to the listed names.

8. Singly susbstituted derivatives do not usually include the prefix 'mono'. This term is used only when required to prevent ambiguity. The absence of a suitable prefix implies 'mono', e.g. Glyceril stearate.

9. The term 'Glyceride' has been utilized to describe a monoglyceride. Mixtures of mono-, di- and triglycerides are referred to as 'Glycerides'. Triglycerides are assigned specific nomenclature, e.g. Tristearin.

10. Multiple substitution is routinely described with the appropriate prefix, such as 'di-', 'tri-' or 'tetra-', e.g. Glyceryl distearate.

11. Names of ingredients, other than colours, that contain terminal numbers are generally hyphenated. Derivatives of hyphenated materials retain the original hyphen.

12. Hydratation states are not usually expressed.

13. Straight-chain alkyl groups are described by their common stem names.

14. Materials containing mixtures of even-carbon chain length fractions are named by the appropriate, commonly used fatty stem term. Materials containing mixtures of even- and odd-carbon chain length fractions are designated by alternate nomenclature.

15. Branched-chain alkyl groups are usually described by the prefix 'iso' followed by the common stem name for the comparable straight-chain group (e.g. Isostearyl alcohol, Isocetyl alcohol). The major exception to this rule is the nomenclature for the Guerbet alcohols. These materials are named chemically (e.g. Octyldodecanol, Decyltetradecanol) except for '2-Ethylhexyl'. '2-Ethylhexyl' is represented by the term 'octyl' due to its widespread usage (e.g. Dioctyl sodium sulfosuccinate, Octyl myristate). Therefore esters or other derivatives of 2-Ethylhexylhexanoic acid are also named as Octanoic acid derivatives (e.g. Iso-decyl octanoate). Straight-chain eight-carbon groups are usually named with the appropriate stem derived from caprylic acid. (See also rules 16 and 17.)

16. The following table has been included to clarify the nomenclature for derivatives of caproic, caprylic and capric acids.

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17. The following table describes the nomenclature applied to straight-chain acids and alcohols. Branched-chain acids and alcohols utilize the names listed in this table preceded by the term 'iso' (e.g. Isosteraric acid). Guerbet alcohols, however, are designated by specific names (e.g. Octyldodecanol). (See also rule 15.)

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18. The nomenclature for ingredients consisting of mixtures of similar materials (e.g. fatty acids, fatty alcohols) is determined on the basis of the chemical identity of the raw material as purchased. Mixtures that reflect the original distribution of components due to their natural source (e.g. coconut) are named utilizing the source stem (e.g. coconut alcohol). If the original natural distribution has been significantly cut or enriched, the mixture is named on the basis of the predominant component.

19. Names of lanolin derivatives usually contain the stem 'lan'.

20. Alkanolamides are named by the specific alkyl amide stem and the appropriate abbreviation, e.g. 'MEA', 'DEA', owing to the widespread use of these denominations.

21. The dimethyl term is omitted and is assumed in all alkyl dimethyl amine oxide names (e.g. Stearamine oxide). Tertiary amine oxides with different substituent groups are named completely (e.g. Dihydroxyethyl stearamine oxide).

22. Quaternary ammonium salts usually have the suffix '-ium' in the stem of the cation. The term 'monium' describes a monomethyl-substituted quaternary nitrogen; 'dimonium' describes a dimethyl-substituted quaternary nitrogen; 'trimonium' describes a trimethyl-substituted quaternary nitrogen.

23. The terms quaternium/polyquaternium are used to describe complex quaternary ammonium salts that do not have a common name or that cannot be named by analogy to established names (e.g. Quaternium-82, Polyquaternium-20).

24. The term 'ampho' has been used as a combining term in the nomenclature for the imidazoline-type amphoteric surfactants. In naming these compounds, this stem is combined with the appropriate stem names for the substituent groupings (e.g. Sodium Cocoamphoacetate).

25. Common fatty stem terms are used to designate the alkyl portion of alkyl imidazoline compounds (e.g. Lauryl Hydroxyethyl Imidazoline) even though one carbon atom of the fatty radical becomes a member of the heterocyclic ring during the materials' manufacture.

26. Biological materials are named by specific terms (e.g. Hyaluronic Acid) when the material has been isolated, purified and chemically characterized. Alternate nomenclature for biologicals (e.g. Glycosamino-glycans or Spleen extract) is utilized to name materials in accordance with the extent of their processing.

27. Cosmetic colorants have INCI names according to the nomenclature used in Annex IV to Directive 76/768/EEC.

28. Hair dye ingredients are named according to chemical structure. In the event that chemical names are very complex, a colour/number combination is used prefixed by the letters 'HC'.

29. Denatured alcohols are designated by the INCI name 'Alcohol denat.'. Alcohol denat. is ethyl alcohol that is denatured with one or more denaturing agents in accordance with the national legislation of each Community Member State.

30. Materials derived from plants are known as botanicals. They have INCI names based on the international Linné designated nomenclature of the genus and the species. Chemical derivatives of botanicals follow the nomenclature rules for chemicals.

31. Name/number combinations are used as INCI names for cosmetic ingredients only where the complexity and/or similarity of ingredients precludes assignment of reasonable nomenclature by any other means. In all cases where arbitrary numbers are used, these numbers are preceded by names suggestive of the structure or the composition of the material. Each name/number combination represents a specific ingredient that is listed in the Inventory. The following name/number series of combinations have been used:

(a) Benzophenone

This term is used for all benzophenone derivatives (e.g. Benzophenone-2).

(b) HC colour

See rule 28.

(c) Quaternium/Polyquarternium

See rule 23.

(d) Hydrofluorocarbon/Hydrochlorofluorocarbon

These terms are used for hydrohalocarbon aerosol propellants (e.g. Hydrofluorocarbon 152a, Hydrochlorofluorocarbon 142b).

(e) Polysilicone

This term is used to describe complex silicone polymers that cannot be named by common names or established conventions for silicone compounds (e.g. Polysilicone-1).

32. Compounded mixtures created by combining several materials are named by listing each ingredient present in descending order of predominance.

33. The INCI names for extracts represent the 'material extracted' and do not include reference to the extracting solvents and/or other diluents that may be present in these materials.

34. Solvents and/or diluents contained in commercially available raw materials such as surfactants, polymers and resins are not normally identified as part of the INCI name.

35. Alkoxylated materials are named by including the alkoxylation level as the average number of moles of ethylene oxide and/or propylene oxide.

Ethoxylates, which are commonly expressed by an approximate molecular weight, are converted to the number of moles using the following table:

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Numerical designations included in alternate chemical names for ethoxylated compounds describe the average number of moles of ethoxylation when stated parenthetically, e.g. Polyethylene glycol (20 000).

Without parenthetical notation, the numerical value identifies molecular weight, e.g. Polyethylene glycol 20 000.

36. Ethoxylated alcohols are named by completing the conventional alcoholic stem name with 'eth' followed by the average number of moles of ethylene oxide.

37. The polyethylene glycol fraction of all other ethoxylated compounds that are not named by rule 6 or 36 is followed by the average number of moles of ethylene oxide.

38. The term 'Pareth' applies to ethoxylated paraffinic alcohols containing both even- and odd-carbon chain length fractions.

39. The term 'Acrylates' is used to describe linear, non-cross-linked copolymers that contain combinations of acrylic acid, methacrylic acid and their simple esters. Similarly, the term 'Crotonate(s)' is used to describe the copolymers that contain combinations of crotonic acid and its simple esters.

40. The name 'Carbomer' is used to describe high molecular weight cross-linked homopolymers of acrylic acid. The cross-linking agent(s) is (are) identified in the ingredient monograph definition. (See also rule 41.)

41. The term 'cross-polymer' is used to describe polymers other than Carbomer that are cross-linked. (See also rule 40.)

ABBREVIATIONS

The following abbreviations are used alone or as combining forms for the naming of cosmetic ingredients in the Inventory:

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() OJ No L 151, 23. 6. 1993, p. 32.