es: THe dyes used, if any, shall @ cpject to the provision of sub) Sched py the Government of India, lule Q of the ee other ingredients: Other ingregi provisions of 1S 4707 (Part.2), Sredients used, if any, shall comply with the shampoo shall comply with the . @ ue: bed in Annexes. Fequirements when tested according to methods p sagaitional requirements for ECO Mark (Optio, general requirements: nal) @ | The product shall conform to rn : th i "performance given in (i) to (y) Rant i jj) The ingredients that go into formulation of cosmetics shall comply with the provisions of IS 4707 (Part 1) and IS 4707 (F a specific requirements as given in the aaua Soe eeir (ii) The product package shall display a list of key ingredients in descending order of quantity present. The product shall not be manufactured from any carcinogenic ingredients. The manufacturer shall produce to BIS environmental consent clearance from the concerned State Pollution Control Board as per the provisions of the Water (Prevention and Control of Pollution) Cess Act, 1977 and the Air (Prevention and Control of Pollution) Act, 1981 along with the authorization, if required under the Environment (Protection) Act, 1986 and the Rules made there under, while applying for ECO Mark. Additionally, provisions of the Drugs and Cosmetics Act, 1940 and the Rules there under shall also be complied with. specific requirements: {) Product shall be dermatologically safe when tested as per 1S 4011. (ii) Biodegradable agents wherever used in cosmetic formulations shall be as per their limit finalized for synthetic detergents for ECO Mark by the technical committee. z (ii) Heavy metals ca v 0 4d (Pb) and arsenic (As 23) shall not exceed 20 and the respective method prescribed in relevantr Cosmetic Science (Sem. Vil eee a ; (b) The containers shall be legibly marked with the following information: (i rial; ‘ > “pete and/or his recognized trade-mark, if any; (ili) Net content in volume for liquids and emulsions and in mass for pastes. (iv) Month and year of manufacturing/packing: Vv) Bat mber, in code or otherwise; o" me, Aeetlire * (month and year to be declared by the manufacturer). Notes: This requirement is exempted: * Incase of pack sizes of 10 g/25 ml or less, and * If the shelf life of the product is more than 24 months. (vii) List of key ingredients. Notes: This is exempted in case of pack sizes of 30 g/60 ml or less, (viii) Any other information required by statutory authorities. (©) BIS certification marking The containers may also be marked with the Standard Mark. 4d () The use of the Standard Mark ig governed by the provisions of the Bureau. Indian Standards Act, 1986 and the Rules and Regulations made thereunder The details of conditions under which the licence for the use of Standard Mark may be granted to manufacturers or producers may be obtained from the ane Indian Standards. (ii)_If the product is covered under ECO Mark with ECO Mark logo besides Standard Mar ECO Mark is applicable to the contents or the package or both, as case may If the product package is not separately covered under ECO Mark shall be clearly mentioned on the product that ECO Mark label is ay contents only, 5. Sampling (a) Representative samples of the ‘material shall be drawn as Prescribed in (b) Tests for all the requirements shall be carried out ona composite (0) The shampoo shall be taken to have conformed to this standar sample passes all the tests, (optional), it shall be suitably marked rk. The label may clearly specifyjence (SOM vill) 9-7 ree bi alle o ANNEXURE - A. yst OF RAW MATERIALS CONVENTIONALLY USED IN FORMULATION OF SURFACTANT BASED SHAMPOOS: “petergens amine salts of lauryl sulphonic acid, ) sodium or potassium or ethanol f o Laury! ether sulphates, 9 sulphated monoglycerides, ) sodium alkyl sulphoacetate, e) Alkyl benzene polyoxyethyl sulphonate, Sodium n-I lauryl sarcosinate, Yoda alpha olefin sulphonates, and i) other detergents. pe: foam stabilizers (a) Ethanolamides or isopropanolamides of fatty acids, (p) Amine oxides, (¢) Cocobetaines, and @ Cocoamidopropyl betaines. A-3: Chelating agents (a) Sodium polyphosphates, (b) Sodium salts of ethylene diamine tetra acetic acid. A-4; Solubilizing agents (a) Urea, (b) Aliphatic alcohols, () Sodium toluene sulphonate, (d) Sodium xylene ee 4-5: Preservatives (a) Alcohols, (b) Formaldehyde, (0) Esters of p-hydroxybenzoic acid, (d) Sorbic acid, and (2) Imidozolidinyl urea.ots Ae Cosmetic Science (Sem. Vill) Table 9.2 [15 No. Title [ 264 : 1976 Nitric acid {second revision} [ 265: 1993 Hydrochloric acid (fourth revision) [ 460: 1985 (Part 1) : Test sieves : (Part 1) : Wire cloth test {fourth revision) | 2088 : 1983 Methods for determination of arsenic {second revision} 3958 : 1984 Methods of sampling cosmetics (first revision} oo Classification of cosmetic raw materials and adjuncts revision} (Part 1): 2001 _| Dyes, colours and pigments {second erally not recognized as safe for use in Cosmet (Part 2) : 2001 List of materials gen {second revision} ; biological ‘examination of cosmetics Methods of test for micro! 14648 : 1999 3. Definitions: (@) Dentifrice: A dentifrice is any substance or combination of substances special prepared for the public for cleaning the accessible surfaces of teeth. (ii) Toothpaste: A toothpaste is defined as a dentifrice in the form of a smoot semisolid homogeneous mass containing acceptable ingredients such ; abrasives/polishing agents, surface active agents, humectants, binding agent, an other appropriate substances for oral health, maintenance. The product can b ion thereof, coloured or white, packed in a suitab| opaque, transparent, or combinati container from which it can be extruded in the form of a continuous mass. 4. Types: The toothpaste shall be of either Type 1 or Type 2. Type 1: Non-Fluoridated Type 2: Fluoridated 5. Requirements: ono- or disaccharides, for exampl (i) Composition: A toothpaste shall not contain m sucrose or other readily fermentable carbohydrates. All the raw materi conform to respective Indian Standards wherever they exist. A list of i conventionally used in the manufacture of tooth paste is given in information only. The dyes and pigments used in margem. VD 9-15 anaryicat cosmelc® ste shall ext fi, geo: er is packed, aoe th Collapsible tube or any other suitable / Per in , 2°C in the form of continuous mass with the i I fo : aon ror eee the application of excessive force which Would 7 inju’ °° nae container. It shall be possible to extrude bulk of the 282 fom the container or the tube starting from the crimped end of ‘he tube cy the tube gradually. on mil? pic: er pri not show any physical sign of deterioration during 9 Fra condition ge and use. When subjected to a temperature of 45 * 2c 10m period of 28 days, the toothpaste shall meet the requirements of the standard. fort cooled £0 @ temperature of 5°C for 1 hour after taking out and pressing tube, pe paste shall be found extrudable from the tube and meet the requirement of this ganar: , ae jing material inertness: The collapsible tubes or any other suitable container i “ a packaging of toothpaste shall not corrode, deteriorate oF cause amination of the toothpaste during normal condition of storage and use. When Srjected 0 2 temper of 45 + 2*C for 10 days, the paste shall then De amined visually by extruding part of the contents. The internal surface of the tube examined after slitting it open and removing the remaining contents. There sign of corrosion, chemical attack or other damage. ‘ acceptance test: The toothpaste shall also comply with the requirements when ™ ested according to the methods given in Annexure B to Annexure G. » shelf life: Shelf life shall be declared by the manufacturer for all types of toothpaste. 1 3 facturing date (month and year) should be mentioned on tube and carton. The expiry date OF "Best use before’ shall be mentioned on the tube and carton. During the shelf life, the product will meet the requirement of the standard. sip Additional Requirements for ECO-Mark (Optional) General requirements (a) The product shall conform to the requirements for quality, safety and performance prescribed under (b) to (e). (b) All the ingredients that go into formulation of cosmetics shall comply with the provisions of IS 4707 (Part 1) and IS 4707 (Part 2). The product shall also meet specific requirements as given in the standard. (0) The product package shall display a list of key ingredients in descending order of quantity present. () The product shall not be manufactured from any carcinogenic ingredients. (e) The manufacturer shall produce to BIS environmental consent clearance from the concerned State Pollution Control Board as per the provisions of the Water1 0aP : 3 Pm ricinoleate jum sulphoricinoleate ‘ jum lauryl sulphate rn alkyl sulphoacetate 2 sodium salt of sulphated monoglyceride sodium lauryl sarcosinate Sodium alpha olefin sulphonate Zoco-amido-propyl-betaine sodium dodecyl benzene sulphonate 1. Sodium lauryl sulphoacetate Coconut monoglyceride sulphonates pioctylsodium-sulphosuccinate # 14, Magnesium lauryl sulphate 15. Sodium alkyl benzene sulphonate 16, Sodium alkyl sulphate 17, Sodium lauryl ether sulphate 18, Coco-betaine 4-13; Humectants The humectants generally 1. Glycerol Sorbitol Maltitol Mannitol used are one or more of those listed below: 2 3 4, 5 6 a &i The binding agents generally used are one or more of those given below, Gum tragacanth Sodium alginate Sodium carboxymethy! cellulose Gelatin Guar gum and its derivatives Xanthan gum Carrageenates Carboxy methyl cellulose Magnesium aluminium silicate - Starch . Hydroxypropyl cellulose . Hydroxyethyl cellulose }. Carbopol . Viscarin 16. Polymers (propylene oxide-ethylene oxide-block copolymer A-1.5: Other Substances 1. Fluorides of sodium and stannous 2. Monofiuorophosphate of ammonium, potassium and sodium 3. Sweeteners, saccharine sodium, aspartame 4. Petroleum jelly-silicon defoaming compounds and mineral oil. 5. Colouring agents 6. Essential oils a 8. 9. SPN OM awnH pe are REGRESS Flavouring agents Astringents . Preservatives 10. Antibacterial agents 11. Antiplaque agentsCosmetic Science 32, Control Pollution) Act, 1981 along with the authorization, if required y applying for ECO Mark. Additionally, provisions of the Drugs and Cosmeticg he 1940 and the Rules thereunder shall also be complied with. (ii) Specific Requirements: f@) radia te be dermatologically safe when tested as per Is 4011. (©) Heavy metals calculated as lead (Pb) and arsenic (as AS203) shall not exceed 25 and 2 ppm respectively, when tested by the respective method prescribe j, Indian Standards. ‘Sr. Requirement No. sf 4 1._| Thermal stability To pass the test 2 | pH 40-90 3. Total Fatty substance content, % by mass, Min S ial} 4. __| Total residue, % by mass, Min pes a S._| Heavy metals (as Pb), parts per million. Max 20 6._| Arsenic (as AS2O3), parts per million. Max 2 7. | Microbial contentylimit | (@) Total viable count cfu/g Not more than 1000 (b) Gram negative pathogens Less than 10 © For creams based on beeswax and borax, the pH shall be between 5.0 to 10.0. © If all the raw materials requiring test for heavy metals and arsenic have been so tested and comply with the requirements, then the manufacturer may not test the finished cosmetic for heavy metals and arsenic. 5. Packing and Marking @ Packing: The material shall be packed in suitable well-closed containers. Gi) Marking: The containers shall be legibly marked with the following information: (a) Name of the material; (b) Manufacturer's name and/or his recciieed trade-mark, if any; (©) Net mass of the material; (d) Month and year of manufacturing/packing; _ © ce reote genes (Ser. VIN) C i $-38 Analytical Cosmetics {q) List of key ingredients; ang Note: + This is exem, i Pted in case of pack si : . . sizes Any other information of 30 9/60 ml or less. | iy The containers may aso be marked required by statutory authorities. 'e Bureau i (wv) If a hee is ee under ECO Mark PRE Vrain) marked with E eee BS Sea The label may clearly specify that ECO Mark package is not separately cove voi ieee or both, as case may be. If the Pee mentioned on thelproclletha eCoNeae ECO Mark Scheme, it shall be clearly lark Label is applicable to contents only. ¢, Sampling () Representative samples of the material shall be drawn as prescribed in IS 3958. (ii) Tests for all the characteristics shall be carried out on the composite sample as per methods referred under Table 9.6, (ii) The material shall be taken to have conformed to the standard if the composite sample passes all the tests. 1. Quality of Reagents Unless specified otherwise, pure chemicals and distilled water (see IS 1070) shall be employed in tests. ANNEXURE-A TEST FOR THERMAL STABILITY A-1: Apparatus A-1.1: A humidity chamber/incubator controlled at 60 to 70 percent relative humidity and 45 + 1°C. A-1.2: Clear glass bottles of around 30 ml capacity with plug and screw on cap for proper closure. 4-2: Procedure With the help of spatula, insert the cream into glass bottle and tap it to settle to the bottom. Fill up to two third capacity of bottle and insert plug and tighten the cap. Keep the filled bottle erect inside the incubator at 45 saaseigi4= ours. The sample shall be taken to have passed the test, if on removal from the incubator shows no oil separation —_or any other phase separation. ae greene