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INDIAN STANDARD OF COSMETICS RAW MATERIALS

Posted in CDSCO

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:

  1. Generally recognized as safe (GRAS), and
  2. 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:

  1. IS4707 (Part I) ‘Classification of cosmetics raw materials and adjuncts: Part 1 Comprising a positive list of dyes pigments and colours, and
  2. 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
1 2 3 4
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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FOR FURTHER ASSISTANCE ON THE COSMETICS GUIDELINES & COSMETICS REGN PLEASE CONTACT–

M/s S.J. EXIM Services- Q-Freight Team
Contact Person: Ravi Shekhar Jha

Mob: +91-9999005379

Web: www.sjeximtech.com / www.q-freight.com

Email: intelconsul@gmail.com    /   rsj@sjeximtech.com

 

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“We provide specialized services / consultancy on the subject matter by deigning solutions & imparting the necessary training, if required. Please provide a detailed outline of your query / requirement through email only preferably”

 

 

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