Introduction and Opinion of the SCCNFP

In the Inventory of ingredients employed in cosmetic products, published in 1996 (OJ L 132 of 1 June 1996), as well as in the drafts for the first update of the Inventory which have been submitted until now to the Commission by the Industry, there is a number of dialkanolamine salts, i.e. of Secondary Dialkanolamines listed in Annex II of the Cosmetics Directive 76/768/EEC (serial number 411) and therefore they must not form part of the composition of cosmetic products.

Their removal from the Inventory had already been suggested by the SCCNFP but, apparently, there were (and probably still there are) some doubts about whether (or not) the salts of secondary dialkanolamines are included in the banning provision, probably because Annex II/411 does not include 'and their salts'. However, all amines occur only in the form of their salts in all the cosmetic products, because all amines are alkaline compounds which are always neutralized by an acidic component (producing their salts) in order to give a finished cosmetic product with about neutral pH. As a matter of fact, their ''function'' as buffering agents, or emulsifiers, or surfactants is due just to the properties of their salts.

Another probable reason for ambiguity may be some peculiarities of the CA Chemical Substance Index Names¹, which are used in the Inventory instead of a Chem./IUPAC name. Namely, according to these nomenclature conventions, the indexing names of salts obey different rules; in many cases the name of a salt is not a traditional chemical name, but it is expressed by a combination of phrases such as ''salt with...(1:1)'' or ''compd. with...''. In the latter case the salt is treated as a ''molecular addition compound'', but for those who are not familiar with this convention, the phrase 'compd. with...' may be interpreted as denoting formation of a covalent bond yielding to an ester or amide (not a salt). Also, names such as di- or triethanolamine are aborted from this indexing system, being replaced by systematic names, such as the following:

2,2'-Iminobis[ethanol] ...................instead of ...... Diethanolamine (DEA)

Bis[2-hydroxyethyl]amine.............. » » ...... » »

1,1',1''-Nitrilotriethanol .................. » » ......Triethanolamine (TEA)

1,1',1''-Nitrilotripropan-2-ol ........... » » ......Triisopropylamine

2,2'-Iminobis[propan-2-ol] ............ » » ...... Diisopropanolamine (DIPA)

1-Aminopropan-2-ol ..................... » » ...... Isopropylamine (MIPA)

The Table I below includes 30 dialkanolamine derivatives presently found in the Inventory and included also in the Draft First Update of the Inventory submitted by COLIPA (European Cosmetic Toiletry and Perfumery Association), plus another 4 analogs found in the last edition of the CTFA' s INCI (International Nomenclature Cosmetic Ingredient) Dictionary (at the end of Table 1). Their chemical names and definitions cited in the Inventory and the INCI Dictionary are given in the left and right columns of Table 1 respectively. Namely :

- The first 24 cosmetic ingredients are diethanolamine salts. This is clearly stated in the respective definitions of the INCI Dictionary (right column); but also the Chem./Iupac names in the Inventory (left column) define exactly the same salts, according to the information given above.

- The remaining six cosmetic ingredients of Table 1 (serial numbers 25-30) are (or contain) salts of diisopropanolamine (DIPA). The first two of them (No. 25-26), are clearly defined as DIPA salts. The remaining four (No.27-30) are (or contain) salts of mixed isopropanolamines, being a special case of controversial denomination. Namely, in the INCI Dictionary the definition of Mixed Isopropanolamines does not correspond to the respective Chem./Iupac name of the Inventory : According to the INCI Dictionary, this INCI name refers to a mixture of Isopropanolamine, Diisopropanolamine and Triisopropanolamine, whereas the INCI name (so-called) of the Inventory denotes a mixture of . Isopropanolamine and Triisopropanolamine only. Apparently, in order to retain this INCI name the COLIPA LCLN simply changed its Chem./Iupac definition. by removing the diethanolamine component of the mixture. Obviously, this was a non-permissible alteration. Two products of different composition are not permitted to have even the same trade name. For chemical names this rule has no exceptions.

On the other hand, the name ''Mixed Isopropanolamines'' itself deviates the most fundamental rule of the Inventory, and of the Cosmetic Directive imposing that each one chemical ingredient will appear on the label. The exceptions from this rule are exclusively the natural products, their derivatives and some polymers.

Clearly, the aforementioned mixed isopropanolamine derivatives must be removed from the Inventory for both reasons mentioned above.

Table 1

	EU Inventory	INCI Dictionary
01	INCI name: DEA-C12-15 ALKYL SULFATE Chem./Iupac: Sulfuric acid, C12-C15-alkyl ester, 2,2'-iminobisethanol salt	DEA-C12-15 Alkyl Sulfate is the diethanolamine salt of the sulfate of C12-15
02	INCI name: DEA-CETEARETH-2 PHOSPHATE	DEA-Ceteareth-2 Phosphate is the diethanolamine salt of Ceteareth-2 Phosphate (q.v.).
03	INCI name: DEA-CETYL PHOSPHATE CAS No: 69331-39-1 Einecs/Elincs: 273-968-7 Chem./Iupac: 1-Hexadecanol, phosphate, compd. with 2,2'-iminobis[ethanol] (1:1).	DEA-Cetyl Phosphate is the diethanolamine salt of cetyl phosphate that conforms generally to the formula
04	INCI name: DEA-CETYL SULFATE CAS No: 51541-51-6 Einecs/Elincs: 257-260-5 Chem./Iupac: Bis(2-hydroxyethyl)ammonium hexadecyl sulphate.	DEA-Cetyl Sulfate is the diethanolamine salt of cetyl sulfate that conforms to the formula
05	INCI name: DEA-COCOAMPHODIPROPIONATE Chem./Iupac: Beta-alanine, N-(2-aminoethyl)-N-[2-(2-carboxyethoxy)ethyl]-, N-coco acyl derivs., 2,2'-iminobisethanol salts	DEA-Cocoamphodipropionate is the amphoteric organic compound that conforms generally to the formula
06	INCI name: DEA-CYCLOCARBOXYPROPYLOLEATE CAS No: 84195-78-8 Einecs/Elincs: 282-385-7 Chem./Iupac: 5(or 6)-carboxy-4-hexylcyclohex-2-ene-1-octanoic acid, compound with 2,2'-iminodiethanol.	DEA-Cyclocarboxypropyloleate is the diethanolamine salt of Cyclocarboxypropyloleic Acid (q.v.). It conforms generally to the formula
07	INCI name: DEA-DODECYLBENZENE SULFONATE CAS No: 26545-53-9 Einecs/Elincs: 247-784-2 Chem./Iupac: Dodecylbenzenesulphonic acid, compound with 2,2'-iminodiethanol (1:1).	DEA-Dodecylbenzenesulfonate is the diethanolamine salt of Dodecylbenzene Sulfonic Acid (q.v.). It conforms to the formula
08	INCI name: DEA-HYDROLYZED LECITHIN CAS No: 91053-51-9 Einecs/Elincs: 293-317-0 Chem./Iupac: Lecithins, reaction products with diethanolamine.	DEA-Hydrolyzed Lecithin is the diethanolamine salt of partially hydrolyzed lecithin.
09	INCI name: DEA-ISOSTEARATE CAS No: 93920-28-6 Einecs/Elincs: 300-113-8 Chem./Iupac: Isooctadecanoic acid, compound with 2,2'-iminodiethanol (1:1).	DEA-Isostearate is the diethanolamine salt of Isostearic Acid (q.v.) that conforms generally to the formula
10	INCI name: DEA-LAURAMINOPROPIONATE CAS No: 65104-36-1 Einecs/Elincs: 265-417-4 Chem./Iupac: N-dodecyl-ß -alanine, compound with 2,2'-iminodiethanol (1:1).	DEA-Lauraminopropionate is the diethanolamine salt of a substituted propionic acid. It conforms generally to the formula
11	INCI name: DEA-LAURETH SULFATE	DEA-Laureth Sulfate is the diethanolamine salt of an ethoxylated lauryl sulfate that conforms generally to the formula
12	INCI name: DEA-LAURYL SULFATE CAS No: 143-00-0 Einecs/Elincs: 205-577-4 Chem./Iupac: Bis(2-hydroxyethyl)ammonium decyl sulphate.	DEA-Lauryl Sulfate is the diethanolamine salt of lauryl sulfate that conforms to the formula
13	INCI name: DEA-LINOLEATE CAS No: 59231-42-4 Einecs/Elincs: 261-676-2 Chem./Iupac: (9Z,12Z)-octadeca-9,12-dienoic acid, compound with 2,2'-iminodiethanol (1:1).	DEA-Linoleate is the diethanolamine salt of linoleic acid that conforms generally to the formula
14	INCI name: DEA-METHOXYCINNAMATE CAS No: 56265-46-4 Einecs/Elincs: 260-082-0 Chem./Iupac: P-methoxycinnamic acid, compound with 2,2'-iminodiethanol (1:1).	DEA-Methoxycinnamate is the diethanolamine salt of methoxycinnamic acid that conforms to the formula In the United States, DEA-Methoxycinnamate may be used as an active ingredient in OTC drug products.
15	INCI name: DEA-METHYL MYRISTATE SULFONATE Chem./Iupac: Tetradecanoic acid, 2-sulfo-, 1-methyl ester, 2,2'-iminobisethanol salt	DEA-Methyl Myristate Sulfonate is an alpha sulfonated fatty acid ester neutralized with diethanolamine. It conforms generally to the formula
16	INCI name: DEA-MYRETH SULFATE	DEA-Myreth Sulfate is the diethanolamine salt of ethoxylated myristyl sulfate that conforms generally to the formula:
17	INCI name: DEA-MYRISTATE CAS No: 53404-39-0 Einecs/Elincs: 258-531-0 Chem./Iupac: Bis(2-hydroxyethyl)ammonium myristate.	DEA-Myristate is the diethanolamine salt of myristic acid that conforms generally to the formula
18	INCI name: DEA-MYRISTYL SULFATE CAS No: 65104-61-2 Einecs/Elincs: 265-433-1 Chem./Iupac: Bis(2-hydroxyethyl)ammonium tetradecyl sulphate.	DEA-Myristyl Sulfate is the diethanolamine salt of myristyl sulfate that conforms to the formula
19	INCI name: DEA-OLETH-10 PHOSPHATE CAS No: 58855-63-3 Chem./Iupac: Ethanol, 2,2'-iminobis-, compd. with (Z)-, a -9-octadecenyl-, ? -hydroxy poly(oxy-1,2-ethanediyl), phosphate	DEA-Oleth-10 Phosphate is the diethanolamine salt of a complex mixture of Oleth-10 Phosphate (q.v.)
20	INCI name: DEA-OLETH-20 PHOSPHATE CAS No: 58855-63-3 Chem./Iupac: Ethanol, 2,2'-iminobis-, compd. with (Z)-, a -9-octadecenyl-, ? -hydroxy poly(oxy-1,2-ethanediyl), phosphate	DEA-Oleth-20 Phosphate is the diethanolamine salt of a complex mixture of Oleth-20 Phosphate (q.v.)
21	INCI name: DEA-OLETH-3 PHOSPHATE CAS No: 58855-63-3 Chem./Iupac: Ethanol, 2,2'-iminobis-, compd. with (Z)-, a -9-octadecenyl-, ? -hydroxy poly(oxy-1,2-ethanediyl), phosphate	DEA-Oleth-3 Phosphate is the diethanolamine salt of Oleth-3 Phosphate (q.v.).
22	INCI name: DEA-OLETH-5 PHOSPHATE CAS No: 58855-63-3 Chem./Iupac: Ethanol, 2,2'-iminobis-, compd. with (Z)-, a -9-octadecenyl-, ? -hydroxy poly(oxy-1,2-ethanediyl), phosphate	DEA-Oleth-5 Phosphate is the diethanolamine salt of a complex mixture of esters of Oleth-5 Phosphate (q.v.).
23	INCI name: DEA-STYRENE/ACRYLATES/DVB COPOLYMER	DEA-Styrene/Acrylates/DVB Copolymer is the diethanolamine salt of a polymer of styrene, divinylbenzene and two or more monomers consisting of acrylic acid, methacrylic acid or their simple esters
24	INCI name: DIETHANOLAMINE BISULFATE CAS No: 59219-56-6 Einecs/Elincs: 261-663-1 Chem./Iupac: Bis(2-hydroxyethyl)ammonium hydrogen sulphate.	Diethanolamine Bisulfate is the salt of diethanolamine that conforms to the formula
25	INCI name: DIPA-HYDROGENATED COCOATE Chem./Iupac: Fatty acids, coco, hydrogenated, salts with bis(2-hydroxypropyl)amine	DIPA-Hydrogenated Cocoate is the diisopropanolamine salt of Hydrogenated Coconut Acid (q.v.).
26	INCI name: DIPA-LANOLATE CAS No: 85536-46-5 Einecs/Elincs: 287-529-2 Chem./Iupac: Fatty acids, lanolin, compds. with isopropanolamine.	DIPA-Lanolate is the diisopropanolamine salt of Lanolin Acid (q.v.).
27	INCI name: MIXED ISOPROPANOLAMINES CAS No: 122-20-3 78-96-6 Einecs/Elincs: 204-528-4 / 201-162-7 Chem./Iupac: 1,1',1''-nitrilotripropan-2-ol / 1-aminopropan-2-ol. Restriction: III/1,61	Mixed Isopropanolamines is a blend of Isopropanolamine (q.v.), Diisopropanolamine (q.v.) and Triisopropanolamine (q.v.).
28	INCI name: MIXED ISOPROPANOLAMINES LANOLATE CAS No: 85536-46-5 85536-47-6 Einecs/Elincs: 287-529-2 / 287-530-8 Chem./Iupac: Fatty acids, lanolin, compds. with isopropanolamine / Fatty acids, lanolin, compds. with triisopropanolamine.	Mixed Isopropanolamines Lanolate is a mixture of amine salts formed by neutralizing lanolin acids with Mixed Isopropanolamines (q.v.).
29	INCI name: MIXED ISOPROPANOLAMINES LAURYL SULFATE CAS No: 68877-25-8 Einecs/Elincs: 244-238-5 / 266-195-1 Chem./Iupac: (2-hydroxypropyl)ammonium decyl sulphate / decyl hydrogen sulphate, compound with 1,1',1''-nitrilotripropan-2-ol.	Mixed Isopropanolamines Lauryl Sulfate is the Mixed Isopropanolamines (q.v.) salt of lauryl sulfate.
30	INCI name: MIXED ISOPROPANOLAMINES MYRISTATE CAS No: 64012-06-2 83292-27-7 Einecs/Elincs: 264-601-1 / 280-371-5 Chem./Iupac: (2-hydroxypropyl)ammonium myristate / tris(2-hydroxypropyl)ammonium myristate.	Mixed Isopropanolamines Myristate is a mixture of amine salts formed by neutralizing myristic acid with Mixed Isopropanolamines (q.v.).

Found only in the INCI Dctionary

DEA-C12-13 Alkyl Sulfate DEA-C12-13 Alkyl Sulfate is the diethanolamine salt of the sulfate of C12-13 Alcohols (q.v.)

DEA-C12-13 Pareth-3 Sulfate DEA-C12-13 Pareth-3 Sulfate is the diethanolamine salt of the sulfate ester of C12-13 Pareth-3 (q.v.)

DEA-C8-18 Perfluoroalkylethyl Phosphate DEA-C8-18 Perfluoroalkylethyl Phosphate is the diethanolamine salt of a complex mixture of esters of phosphoric acid and a perfluoroalkylethyl alcohol containing 8 to 18 carbons in the alkyl chain.

DEA-Perfluoropolymethylisopropeth Phosphate DEA-Perfluoropolymethylisopropeth Phosphate is the diethanolamine salt of a complex mixture of esters of phosphoric acid and Perfluoropolymethylisopropyl Ether (q.v.).

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¹ As known, the IUPAC nomenclature system has been modified by the Chemical Abstracts Service to a system of Naming and Indexing of Chemical Abstracts for CHEMICAL ABSTRACTS based, first, on Inverted names and, second, on numerous rules of precedence for the selection of the parent compounds intended to appear first in the inverted names (like real parents of a family of compounds).