INDIAN STANDARD OF COSMETICS RAW MATERIALS

Dated: 10.08.2019

INDIAN STANDARD CLASSIFICATION OF COSMETICS RAW MATERIALS AND ADJUNCTS (IS 4707 PART – I)

This Indian Standard (Part I) (Second Revision) was adopted by the Bureau of Indian Standards, after the draft finalized by the Cosmetics Sectional Committee had been approved by the Petroleum, Coal and Related Products Division Council.

This standard was originally published in 1968. First revision of this standard was carried out in 1988. In this revision only those colours which were in vogue in Indian Cosmetics industry and had either EEC (European Economic Community), USFDA (United States Food & Drug Administration) or any international approval were incorporated.

In this revision, list of dyes, pigments and colours have been updated in accordance with the current EEC Directive 76/768/EEC. A restricted number of colours currently in vogue in Indian Industry have been taken from this Directive keeping in mind, a wide list of colour would be difficult to monitor. Moreover, list of colouring agents permitted for use in the cosmetic products have been prepared as per their Colour Index Number in the ascending order along with colour, field of application and other limitations and requirements for use.

Considering the ill effects of spurious cosmetics, the Cosmetic Sectional Committee, in the absence of effective regulations or standards had broadly classified the ingredients for use in cosmetics into the following two categories:

Generally recognized as safe (GRAS), and
Generally not recognized as safe (GNRAS).

The Committee had felt that for dyes, pigments and colours, it would be more convenient and practical to list them under GRAS class only and for raw materials other than dyes, pigments and colours, it would be convenient to prepare GNRAS list since this list would adequately safeguard the interest of consumers, leaving enough room for development of newer raw material.

Therefore, IS 4707 was originally published in two parts namely:

IS4707 (Part I) ‘Classification of cosmetics raw materials and adjuncts: Part 1 Comprising a positive list of dyes pigments and colours, and
IS 4707 (Part II) ‘Classification of cosmetics raw materials and adjuncts: Part 2 Comprising a negative list of raw material’ which shall not form part of the composition of cosmetic products, along with a list of substances which cosmetic products shall not contain except subject to restrictions and conditions laid down.

There is no International Standard published by the International Organization for Standardization (ISO) on the subject at present.

Indian standard

CLASSIFICATION OF COSMETICS

RAW MATERIALS AND ADJUNCTS

PART 1 DYES, COLOURS AND PIGMENTS

(Second Revision)

1 SCOPE 1.1 This standard (Part 1) lists dyes, colours and pigments which are generally recognized as safe (GRAS) for use in cosmetics. The list also includes colourants which are intended for use in toiletry preparations.	4 LIST OF COLOURING AGENTS ALLOWED FOR USE IN COSMETIC PRODUCTS 4.1 The GRAS list of colouring agent is given in Table 1. 4.2 Field of Application
	Column 1:	Colouring agents allowed in all cosmetics products.
2 Reference Indian Standard IS 4707 (Part 2): 2001 ‘Classification of cosmetics raw materials and adjuncts: Part 2. List of raw materials generally not recognized as safe for use in cosmetics (*second revision*)’ is a necessary adjunct to this standard.	Column 2:	Colouring agents allowed in all cosmetic products except those intended to be applied in the vicinity of the eyes, in particular eye make-up and eye make-up remover.
3 Terminology 3.1 ‘Gras’ List – Shall include ingredients which are generally recognized as safe and which when used in concentrations conventionally adopted or within the limits as specified (wherever applicable) shall be permissible in cosmetics.	Column 3:	Colouring agents allowed exclusively in cosmetic products intended not to come into contact with the mucous membranes.
	Column 4:	Colouring agents allowed exclusively in cosmetic products intended to come into contact only briefly with the skin.
	NOTE – Lakes or salts of these colouring agents using substances not prohibited under IS 4707 (Part 2) or not excluded under Annex A from the scope of this standard are equally allowed.

GRAS List of Colouring Agents

Colour Index Number or Denomination	Colour	Field of Applications				Other Limitations and Requirements
Colour Index Number or Denomination	Colour	1	2	3	4	Other Limitations and Requirements
10006	Green				´
10020	Green			´
10316²⁾	Yellow		´
11680	Yellow			´
11710	Yellow			´
11725	Orange				´
11920	Orange	´
12010	Red			´
12085²⁾	Red	´				3% Max concentration in the finished product
12120	Red				´
12150	Red	´
12370	Red				´
12420	Red				´
12480	Brown
12490	Red	´
12700	Yellow
13015	Yellow	´				E 105
14270	Orange	´				E 103
14700	Red	´
14720	Red	´
14815	Red	´				E 125
15510²⁾	Orange		´
15525	Red	´
15580	Red	´
15620	Red				´
15630²⁾	Red	´				3% Max concentration in the finished product
15800	Red			´
15850²⁾	Red	´
15865²⁾	Red	´
15880	Red	´
15980	Orange	´				E 111
15985²⁾	Yellow	´				E 110
16035	Red	´
16185	Red	´				E 123
16230	Orange
16255²⁾	Red	´				E 124
16290	Red	´				E 126
17200²⁾	Red	´
18050	Red
18130	Red			´
18690	Yellow				´
18736	Red				´
18820	Yellow				´
18965	Yellow	´			´
19140²⁾	Yellow	´				E 102
20040	Yellow				´	Maximum 3, 3’-dimethyl benzidline concentration in the colouring agent 5 ppm
20170	Orange			´
20470	Black				´
21100	Yellow				´	Maximum 3, 3’-dimethyl benzidine concentration in the colouring agent 5 ppm
21108	Yellow				´	-do-
21230	Yellow			´
24790	Red				´
26100	Red			´		· Purity criteria aniline £ 0.2% · 2-naphtol £ 0.2% · 4-aminoazobenzene £ 0.1% · 1-(phenylazo)-2-napthtol £ 3% · 1-[2-(phenylazo) phenylazo]-2-naphtalenol £ 2%
27290²⁾	Red				´
27755	Black	´				E 152
28440	Black	´				E 151
40215	Orange				´
40800	Orange	´
40820	Orange	´				E 160 e
40825	Orange	´				E 160 f
40850	Orange	´				E 161 g
42045	Blue			´
42051²⁾	Blue	´				E 131
42053	Green	´
42080	Blue				´
42090	Blue	´
42100	Green				´
42170	Green				´
42510	Violet			´
42520	Violet				´	5ppm Mass concentration in the finished product
42735	Blue			´
44045	Blue			´
44090	Green	´				E 142
45100	Red				´
45190	Violet				´
45220	Red
45350	Yellow	´				6% Max concentration in the finished product
45370²⁾	Orange	´				Not more than 1% 2-6(hydroxyl-3-oxo-3H-xanthen-9-yl) benzoic acid and 2% 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid
45380²⁾	Red	´				-do-
45396	Orange	´				When used in lipstic, the colouring agent is allowed only in free acid form and in a maximum concentration of 1%
45405	Red		´			Not more than 1% 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid and 2% 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid
45410²⁾	Red	´				-do-
45425	Red	´				Not more than 1% 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid and 3% 2-(iodo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid
45430²⁾	Red	´				E 127, -do-
47000	Yellow			´
47005	Yellow	´				E 104
50325	Violet				´
50420	Black			´
51319	Violet				´
58000	Red	´
59040	Green			´
60724	Violet				´
60725	Violet	´
60730	Violet			´
61565	Green	´
61570	Green	´
61585	Blue				´
62045	Blue				´
69800	Blue	´				E 130
69825	Blue	´
71105	Orange			´
73000	Blue	´
73015	Blue	´
73360	Red	´
73385	Violet	´
73900	Violet				´
73915	Red				´
74100	Blue				´
74160	Blue	´
74180	Blue				´
74260	Green		´
75100	Yellow	´
75120	Orange	´				E 160 b
75125	Yellow	´				E 160 d
75130	Orange	´				E 160 a
75135	Yellow	´				E 161 d
75170	White	´
75300	Yellow	´				E 100
75470	Red	´				E 120
75810	Green	´				E 140 and E 141
77000	White	´				E 173
77002	White	´
77004	White	´
77007	Blue	´
77015	Red	´
77120	White	´
77163	White	´
77220	White	´				E 170
77231	White	´
77266	Black	´
77267	Black	´
77268¹⁾	Black	´				E153
77288	Green	´				Free from chromate ion
77289	Green	´				Free from chromate ion
77346	Green	´
77400	Brown	´
77480	Brown	´				E175
77489	Orange	´				E172
77491	Red	´				E172
77492	Yellow	´				E172
77499	Black	´				E172
77510	Blue	´				Free from cyanide ions
77713	White	´
77742	Violet	´
77745	Red	´
77820	White	´				E174
77891	White	´				E171
77947	White	´
Lactoflavin	Yellow	´				E101
Caramel	Brown	´				E150
Capsanthin, Capsorubin	Orange	´				E160c
Beetroot red	Red	´				E162
Anthocyanins	Red	´				E163
Aluminimum, zinc, magnesium and calcium stearates	White	´
Bromothymol blue	Blue				´
Bromocreso green	Green				´
Acid Red 195	Red			´
*NOTE –* No colourant is listed in this standard which is provisionally allowed for use in cosmetic products. ¹⁾Colouring agents whose number is preceded by the letter “E” in accordance with the EEC Directive of 1962 concerning foodstuffs and colouring matters must fulfil the purity requirements laid down in those Directives. ²⁾ The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. They must pass the test for insolubility which will be determined by the procedure laid down in EEC.

ANNEX A

LIST OF SUBSTANCES EXCLUDED FROM THE SCOPE OF THE DIRECTIVE

Strontium and its compounds, with the exception of Strontium Lactate, Strontium Nitrate and Strontium Polycarboxylate listed in Annex B of IS 4707 (Part 2), Strontium Chloride, Strontium Acetate, Strontium Hydroxide, Strontium Peroxide under the conditions laid down in Annex A of IS 4707 (Part 2) and of strontium lakes, pigments and salts of the colouring agents listed with the reference (4) in this standard.

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