Dated: 12.08.2019
INDIAN STANDARD OF COSMETICS RAW MATERIALS- LIST OF PRESERVATIVES WHICH COSMETIC PRODUCTS MAY CONTAIN (IS 4707 PART – II)
This Indian Standard (Part 2) (Third Revision) was adopted by the Bureau of Indian Standards, after the draft finalized by the Cosmetic Sectional Committee had been approved by the Petroleum, Coal and Related Products Division Council.
This standard was first published in 1973 and revised to publish it in two parts.
Part 1 Dyes, colours and pigments
Through use of the both standards particularly (Part 2), the Committee felt that preparation of such a list is an effective step in guarding against harmful substances being used in formulation of cosmetics. This standard was essentially based on EEC Directive 76/768 with marginal differences in certain parameters in line with restrictions given in Drugs and Cosmetics Act, and Rules 1945 (such as permissible limits of fluoride in dentifrice and m-, p- phenylene diamines for use in hair dyes). Substances, which were provisionally allowed by EEC Directive were not included in this standard.
In the second revision the list was updated to include new materials which either should not form part of cosmetics or to be used with restrictions. This updation was done again based on EEC Directives 2001.
The present revision has also been taken up to align and update the standard with the provisions of EEC Directive 76/768/EEC-2007 currently in vogue.
There is no ISO Standard published by the International Organization for Standardization on the subject title at present.
Indian Standard
CLASSIFICATION OF COSMETICS RAW MATERIALS
AND ADJUNCTS
PART 2 LIST OF RAW MATERIALS GENERALLY NOT RECOGNIZED
AS SAFE FOR USE IN COSMETICS
(Third Revision)
| 1 SCOPE
This standard (Part 2) lists cosmetics raw materials and adjuncts, other than dyes, colours and pigments in the following four groups: a) List of substances classified as ‘GNRAS’ which must not form part of the composition of cosmetic products (See Annex A), b) List of substances which cosmetic products must not contain except subject to the restrictions and conditions laid down (See Annex B), c) List of preservatives allowed (See Annex C), and d) List of U.V. filters allowed in sunscreen products (See Annex D). |
2.2 ‘GNRAS’ List – Ingredients which are generally not recognized as safe and which shall not be permissible either in any amount whatsoever or in amounts exceeding those specifically laid down for cosmetics.
2.3 Preservatives – Substances which may be added to cosmetic products for the primary purpose of inhibiting the development of micro-organisms in such products. 2.4 U.V. Filters – U.V. filters are substances used in cosmetic sunscreen products, which are specifically intended to filter certain U.V. rays in order to protect the skin from certain harmful effects of these rays. |
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| 2 Terminology
For the purpose of this standard, the following definitions shall apply: 2.1 ‘GRAS’ List – Ingredients which are generally recognized as safe and which has been used in concentration conventionally adopted shall be permissible in cosmetics.
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Note– Any ingredients classified as ‘GNRAS’ (See Annex A) may be present as an impurity when its concentration is less than what can be detected by standard analytical method. It shall not, however, be used as a component of a preparation. | |
| 3 GNRAS LISTS FOR INGREDIENTS OTHER THAN DYES PIGMENTS AND COLOURS
All the ingredients prescribed in this standard have been classified as per the following four lists: a) Annex A — List of substances which must not form part of the composition of cosmetic products. (Posted yesterday on 11.08.2019 Please read our yesterdays post) b) Annex B — List of substances which cosmetic products must not contain except subject to the restrictions and conditions laid down. (Posted yesterday on 11.08.2019 Please read our yesterdays post) c) Annex C — List of preservatives which cosmetic products may contain. d) Annex D — List of U.V. filters which cosmetic sunscreen products may contain. |
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LIST OF PRESERVATIVES WHICH COSMETIC PRODUCTS MAY CONTAIN
- Preservatives are substances which may be added to cosmetic products for the primary purpose of inhibiting the development of micro-organisms in such products.
- The substances marked with the symbol (*) may also be added to cosmetic products in concentration other than those laid down in this Annex for other specific purposes apparent from the presentation of the products, e.g.; deodorants in soaps or as and-dandruff agents in shampoos.
- Other substances used in the formulation of cosmetic products may also have anti-microbial properties and thus help in the preservation of the products, as, for instance, many essential oils and some alcohols. These substances are not included in this Annex.
- For the purposes of this list:
- a) ‘Salts’ is taken to mean: salts of the cations sodium, potassium, calcium, magnesium, ammonium and ethanolamines; salts of the anions chloride, bromide, sulphate, acetate.
- b) ‘Esters’ is taken to mean: esters of methyl; ethyl, propyl, isopropyl, butyl, isobutyl, phenyl’
- All finished products containing formaldehyde or substances in this Annex and which release formaldehyde must be labelled with the warning ‘contains formaldehyde where, the concentration of formaldehyde in the finished product exceeds 0.05 percent.
| SI
No. |
Substance | Maximum Authorized Concentrator | Limitations and Requirements
|
Conditions of use and warnings which must be Printed on the Label |
| (1) | (2) | (3) | (4) | (5) |
| 1. | Benzoic acid (CAS No. 65-85-0) and its sodium salts (CAS No. 532-32-1) | Rinse off products except oral care products: 2.5 (acid)
Oral care products: 1.7 percent (acid) Leave-on products: 0.5 percent (acid) |
||
| 1a. | Salts of benzoic acid other than listed under reference No.1 and esters of benzoic acid | 0.5 percent (acid) | ||
| 2. | Propionic acid, its salts and esters (*) | 2 percent (acid) | ||
| 3. | Salicylic acid, its salts and esters (•) | 0.5 percent (acid) | Not to be used In preparation for children under three years of age except for shampoos | Not to be used for children under three yeas of 8P, (‘) |
| 4. | Sorbic acid (hexa-2,4-diesoic acid) and its sales (*) | 0.6 percent (acid) | ||
| 5. | Formaldehyde and paraformaldehyde
|
0.2 percent (except for products for oral hygiene)
0.1 percent (products for oral hygiene) expressed as free formaldehyde |
Prohibited in aerosol dispensers (sprays) | |
| 6. | Biphenyl-2-ol(o-phenylphenol) and its salts(*) | 0.2 percent expressed as the phenol | ||
| 7. | Zinc pyrithione (INN) (CAS No. 13463-41-7) | Hair products: 1.0 percent.
Other products: 0.5 percent |
Rinse off product only
No use in products for oral hygiene |
|
| 8. | Inorganic sulphites and hydrogen sulphites(*) | 0.2 percent expressed as free SO2 | ||
| 9. | Sodium iodate | 0.1 percent | Rinse off product only | |
| 10. | Chlorobutanol (INN) | 0.5 percent | Prohibited in aerosol dispensers (sprays) | Contain chlorobutanol |
| 11. | 4-Hydroxybenzoic acid and its salts and esters(*) | 0.4 percent (acid) for 1 ester
0.8 percent (acid) for mixtures of esters |
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| 12. | 3-Acetyl-6-methylpyran-2,4(3H)-dione (Dehydracetic acid) and it’s salts | 0.6 percent (acid) | Prohibited in aerosol dispensers (sprays) | |
| 13. | Formic acid and its sodium salt (*) | 0.5 percent (expressed as acid) | ||
| 14. | 3,3′-Dibromo-4,4′ hexamethylenedioxydi- benzamidine (Dibromohexamidine) and its salt (including isethionate) | 0.1 percent | ||
| 15. | Thiomersal (INN) | 0.007 percent (of Hg)
If mixed with other mercurial compounds authorized by this standard, the maximum concentration of Hg remain fixed at 0.007 percent. |
For eye make up and eye make-up remover only | Contains thimersal |
| 16. | Phenylmercuric salts (including borate) | 0.007 percent (of Hg)
If mixed with other mercurial compounds authorized by this standard, the maximum concentration of Hg remains fixed at 0.007 percent. |
For eye make up and eye make-up remover only | Contain phenylmercuric compounds |
| 17. | Undec-10-enoic and salts (*) | 0.2 percent (acid) | ||
| 18. | Hexetidine (INN) (*) | 0.1 percent | ||
| 19. | 5-Bromo-5-nitro-1,3-dioxane | 0.1 percent | Rinse off product only | |
| 20. | Bronopol (INN) (*) | 0.1 percent | Avoid formation of nitrosamines | |
| 21. | 2,4-Dichlorobenzyl alcohol (*) | 0.15 percent | ||
| 22. | Triclocarbon (INN) (*) | 0.2 percent | Purity criteria: 3,3′,4,4′-Tetrachloroazobenzene <1ppm 3,3′,4,4′-Tetrachloroazoxybenzene <1ppm | |
| 23. | 4-Chloro-m-cresol (*) | 0.2 percent | Prohibited in product intended to come Into contact with mucous membrancs | |
| 24. | Triclosan (INN) (*) | 0.3. percent | ||
| 25. | 4-Chloro-3.5. xylenol (*) | 0.5 percent | ||
| 26. | 3,3′-Bis (1-hydroxymethyl-2,5-dioxoimidazolidin-4-yl)-1.1′-methylen ediurea (‘Imidazo lidinyl urea’ (*) | 0.6 percent | ||
| 27. | Poly (1-hexamethyle nebiguanide hydrochloride (*) | 0.3 percent | ||
| 28. | 2-Phenoxyethanol (*) | 1.0 percent | ||
| 29. | Hexamethylenetetramine (*) (methenamine) (INN) | 0.15 percent | ||
| 30. | Methenamines 3-chloallylochloride (INNM) | 0.2 percent | ||
| 31. | 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)3,3-dimethylutan-2-one (*) | 0.5 percent | ||
| 32. | 1,3-Bis (hydroxymethyl)-5-5-dimethylimidazolidine-2,4-dione(*) | 0.6 percent | ||
| 33. | Benzyl alcohol (*) | 1.0 percent | ||
| 34. | 1-Hydroxy-4-methyl-6(2,4,4-trimethyl pentyl)2-pyridon and its monoethanolamine salt (*) | a) 1.0 percent
b) 0.5 percent |
a) Product rinse off
b) For other products |
|
| 35. | 6,6-Dibromo-4,,-dichloro2,2′-methylene-diphenol (Bromochlorophen) (*) | 0.1 percent | ||
| 36. | 4-Isopropyl-m-cresol | 0.1 percent | ||
| 37. | Mixture of 5-Chloro-2-methyl-isothiazl-
3(2H) one and 2- methylisothiazol-3(2H).one with magnesium chloride and magnesium nitrate |
0.0015 percent (of a mixture is the ratio 3:1 of 5- chloro-2-methylisolthiazol 3(2H).one and 2-methylisothiazol-3 (2H)-one | ||
| 38. | 2-Benzyl-4-chlorophenol (clorophene) | 0.2 percent | ||
| 39. | 2-Chloroacetamide | 0.3 percent | ||
| 40. | Chlorhexidine (INN) and its digluconate, diacetate and dihydrochloride | 0.3 percent expressed as chlorhexidine | ||
| 41. | 1-Phenoxypropan-2-ol | 1.0 percent | Only for rinse-off products | |
| 42. | Alkyl (C12 – C22) trimethyl ammonium, bromide and chloride | 0.1 Percent | ||
| 43. | 4.4.dimethyl-1,3-oxizalidine | 0.1 percent | The pH of the finished product-must not be lower than 6 | |
| 44. | N(Hydroxymethyl)-N-(dihydroxymethyl-1.3-dioxo-2,5-imidazolidinyl-4) –N- (hydroxymethyl) urea | 0.5 percent | ||
| 45. | 1,6-Di (4-midinophenoxy)-n-hexane (Hexamidine) and its salts (including isethionate and p-hydroxybenzoate)(+) | 0.1 percent | ||
| 46. | Glutaraldehyde (Pentane 1,5-dial) | 0.1 percent | Prohibited in aerosols (sprays) | Contains glut-araldehyde (where glutar- aldehyde concentration in the finished products exceed 0.05 percent) |
| 47. | 5-Ethyl-3,7-dioxa-1-azabicyclo (3,3,0) octane | 0.3 percent | Prohibited in oral hygiene products and in products intended to come into contact with mucous membranes | |
| 48. | 3-(p-chlorophenoxy)-propane 1,2 diol (chlorphenesin) | 0.3 percent | ||
| 49. | Sodium hydroxylmet- hylamino acetate (Sodium Hydroxyme- thy lglycinate) | 0.5 percent | ||
| 50. | Silver chloride deposited on titanium dioxide | 0.004 percent calculated as AgCI | 20 percent AgCI (W/W) on TiO2, Prohibited in products for children under three years of age, in oral hygiene products and in products intended for application around the eyes and on the lips. | |
| 51. | Benzethonium Chloride (INCI) | 0.1 percent | a) Rinse-off products
b) Leave-on products other than for oral care use. |
|
| 52. | Belzalkonium Chloride, bromide and saccharinate | 0.1 percent calculated as benzalkonium chloride | Avoid contact with eyes. | |
| 53. | Benzylthemiformal | 0.15 percent | Only for products to be removed by rinsing | |
| 54. | 3-Iodo-2-propynylbu-tylcarbamate | 0.05 percent | a) Not to be used for oral hygiene and lipcare products.
b) If the concentration in products intended to remain on the skin exceed 0.02 percent add the phrase: Contains iodine |
Contains iodine |
| 55. | Methylisothiazolinone (INCI) | 0.01 percent |
ANNEX D
(Clauses 1 and 3)
LIST OF PERMITTED UV FILTERS WHICH COSMETIC PRODUCTS MAY CONTAIN
For the purpose of this Directive. UV Filters are substances, which contained in cosmetic sunscreen products, are specifically intended to filter certain UV rays in order to protect the skin from certain harmful effects of these rays.
These UV filters may bee added to other cosmetic products within the limits and under the condition laid down in this Annex.
Other UV filters used in cosmetic products solely for the purpose of protecting the product against UV rays are not included in the list.
| Sl. No. | Substance | Minimum Authorized Concentration | Other Limitation and Requirements | Conditions of Use and Warnings which
must be Printed on the Label |
| (1) | (2) | (3) | (4) | (5) |
| 1. | 4-Aminobenzoic acid | 5 percent | – | – |
| 2. | N,N,N-Trimethyl-4-(2-oxoborn-3-yliden-methyl) aluminum methyl sulphate | 6 percent | – | – |
| 3. | Homosalate (INN) | 10 percent | – | – |
| 4. | Oxybenzone (INN) | 10 percent | – | – |
| 5. | 2-phenylbenzimidazole-5-sulphonic acid and its potassium, sodium and triethanolamine salts | 8 percent (expressed as acid) | – | – |
| 6. | 3,3′-(1.4-Phenylenedimeth-ylene) bis (7,7-dimethyl-2-oxobicyclo-[2,2,1] hept-1-yl-methanesulfonic acid) and its salt. | 10 percent (expressed as acid) | – | – |
| 7. | 1-(4-teri-butylphenyl)-3-(4-methoxy-phenyl) propane-1,3-dione | 5 percent | – | – |
| 8. | Alpha-(2-Oxoborn-3-ylidene)-4-sulphonic acid and its salts | 6 percent (expressed as acid) | – | – |
| 9. | 2-cyano-3,3-diphenyl acrylic acid, 2-ethylhexyl ester(octocrylene) | 10 percent (expressed as acid) | – | – |
| 10. | Polymer of N-(2 and 4)-(2-oxoborn-3-ylidene)methyl) benzyl) acrylamide | 6 percent | – | – |
| 11. | Octyl methoxycinnamate | 10 percent | – | – |
| 12. | Ethoxylated Ethyl-4-Amino-benzoate (PEG-25 PABA) | 10 percent | – | – |
| 13. | Isopentyl-4-methoxycinna-mate (Isoamyl p-Methoxyci-nnamate) | 10 percent | – | – |
| 14. | 2,4,6-trianilino-(p-Carbo-2′-Ethylhexyl-1′ Oxy)- 1,3,5-Triazine (Octyl Triazone) | 5 percent | – | – |
| 15. | Phenol,2-(2H-Benzotriazol-2-yl)-4-Methyl-6-(2-Methyl-3-(1,3,3,3-Tetra-methyl-I- (Trimethylsilyl)Oxy)-Disilox-anyl)Propyl) (Drometrizole Trisiloxane) | 15 percent | – | – |
| 16. | Benzoic acid, 4,4-((6-(((1,1-dimethylethyl) amino)carbony)phenyl)amino)1,3,5-triazine-2,4-diyl)dimino)bis,bis-(2-ethylhexy)ester) | 10 percent | – | – |
| 17. | 3-(4′-Methylbenxylidene)-d-1 champhor (4- Methylbenzylidene Camphor) | 4 percent | – | – |
| 18. | 3-Benzylidene camphor (3-benzylidene Camphor) | 2 percent | – | – |
| 19. | 2-Ethylhexyl salicylate (Octyl-salicylate) | 2 percent | – | – |
| 20. | 4-Dimethl-amino-benzoate of ethyl-2-hexyl (octyldimethyl PABA) | 8 percent | – | – |
| 21. | 2-Hyroxy-4-methoxybenzo-phenone-5-sulfonic acid (Benzophenone-5) and its sodium salt | 5 percent (of acid) | – | – |
| 22. | 2,2′-Methylene-bis-6-(2H-Benzotriazol-2yl)-4-(teramethyl-butyl)-1,1,3,3-phenol | 10 percent | – | – |
| 23. | Monosodium salt of 2-2′-bis-(1,4-pheny-lene)1H-benzimidazole-4,6-disulphonic acid) | 10 percent (of acid) | – | – |
| 24. | (1,3,5)-Triazine-2,4-bis(4-(2-ethyl-hexy-loxy)-2-hydroxy)-phenyl)-6(4-methoxy-phenyl) | 10 percent | – | – |
| 25. | Dimethicodiethy lbenzalmalonate (CAS No. 207574-74-1) | 10 percent | – | – |
| 26. | Titanium dioxide | 25 percent | – | – |
| 27 | Benzoic acid, 2-[-4-(diethylamino)-2-hydroxybenzoyl], hexylester (INCI name: Diethylamino Hydorxyben-zoyl Hexyl Benzoate; (CAS No. 302776-68-7) | 10 percent in sunscreen products |
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