INDIAN STANDARD OF COSMETICS RAW MATERIALS- LIST OF PRESERVATIVES WHICH COSMETIC PRODUCTS MAY CONTAIN (IS 4707 PART – II)

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.

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.

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.

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
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

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

DISCLAIMER: PLEASE REFER TO OFFICIAL SOURCES BEFORE EFFECTING A DECISION

“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”

S J EXIM Services