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.
CLASSIFICATION OF COSMETICS
RAW MATERIALS AND ADJUNCTS
PART 1 DYES, COLOURS AND PIGMENTS
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.|
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.|
3.1 ‘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|
|120852)||Red||´||3% Max concentration in the finished product|
|156302)||Red||´||3% Max concentration in the finished product|
|20040||Yellow||´||Maximum 3, 3’-dimethyl benzidline concentration in the colouring agent 5 ppm|
|21100||Yellow||´||Maximum 3, 3’-dimethyl benzidine concentration in the colouring agent 5 ppm|
|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%
|40820||Orange||´||E 160 e|
|40825||Orange||´||E 160 f|
|40850||Orange||´||E 161 g|
|42520||Violet||´||5ppm Mass concentration in the finished product|
|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|
|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|
|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-|
|75120||Orange||´||E 160 b|
|75125||Yellow||´||E 160 d|
|75130||Orange||´||E 160 a|
|75135||Yellow||´||E 161 d|
|75810||Green||´||E 140 and E 141|
|77288||Green||´||Free from chromate ion|
|77289||Green||´||Free from chromate ion|
|77510||Blue||´||Free from cyanide ions|
|Aluminimum, zinc, magnesium and calcium stearates||White||´|
|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.
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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