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RAW MATERIALS PRODUCT: ANDREW JOSE JLIFE CATCH A WAVE CURL DEFINING SHAMPOO PRODUCT CODE: UM0362 RM
TRADE NAME
0111
Vitamin E Acetate
0142
Salt PVD
0182
D-Panthenol
0207
Tetrasodium EDTA
0288
Purified Water
0393
Allantoin
0419
Cremophor RH40
0713
Abil 9950
0714
Euxyl K100
0997
Tegobetaine F50
1310
SLES 28% Euxyl preserved (0.1%); Steol CS230-E
1454
Lamesoft PO65
1780
Hydrotriticum PVP 25/75
1817
Seamoss/Seacare
2119
Silicone SME 253
2213
Perfume Vibrant Days 157108
28 July 2003 DP1177D; UD9935; UD10294 21 November 2003 Euxyl Mg salts added
RM INFO PRODUCT: ANDREW JOSE JLIFE CATCH A WAVE CURL DEFINING SHAMPOO PRODUCT CODE: UM0362 RM
TRADE NAME
INCI
INCI - HARM
WT% ACT
Surfactant
SUPPLIE WT% R 35 NEVER Stepan
1310
SLES 28% Euxyl preserved (0.1%); Steol CS230-E
0997
Tegobetaine F50
Sodium laureth sulfate 28% & Benzyl alcohol (0.02%) & Methylchloroisothiazolinone(0.0005 %) & Methylisothiazolinone & Magnesium chloride 0.001% & Magnesium nitrate 0.022% Cocamidopropyl betaine 36%
Sodium laureth sulfate 28% & Benzyl alcohol R36/38 (0.02%) & Methylchloroisothiazolinone(0.0005%) & Methylisothiazolinone (0.0002) Magnesium chloride 0.001% & Magnesium nitrate 0.022% Cocamidopropyl betaine 36% R36
Antistat; Cond N
NEVER Goldsch 12
4.32
0142
Salt PVD
Sodium chloride
Sodium chloride
Viscosifier
N
NEVER NCS
1
1
1454
Lamesoft PO65
Surfactant
N
NEVER Cognis
2
Abil 9950
Coco-glucoside 30% & Glyceryl Coco-glucoside 30% & Glyceryl oleate 30% R41; oleate 30% R36/38 Dimethicone propyl PG-betaine 30% Dimethicone propyl PG-betaine 30% NH
Conditioner
N
1985
0.6 0.6 0.15
0713 0182
D-Panthenol
Panthenol
Panthenol
NH
Moisturiser
N
1998 DT Basf
0.2
0.2
0111
Vitamin E Acetate
Tocopheryl acetate
Tocopheryl acetate
NH
Moisturiser
N
1989
Basf
0.2
0.2
0393
Allantoin
Allantoin
Allantoin
NH
Skin Cond.
N
1985
0207
Tetrasodium EDTA
Tetrasodium EDTA
Tetrasodium EDTA
R36/38
Chelant
N
1980
0714
Euxyl K100
N
1985
Hydrotriticum PVP 25/75 Silicone SME 253
Benzyl alcohol 20% & Methylchloroisothiazolinone 0.5% & Methylisothiazolinone 0.2% Water (Aqua) 75% & Hydrolyzed wheat protein/PVP crosspolymer 25% 30% Amodimethicone 20% & C11-15 Pareth7 & Laureth-9 & Glycerin & Trideceth-12
R34; R43; Preservative R52/53
1780
Benzyl alcohol 20% & Methylchloroisothiazolinone0.5% & Methylisothiazolinone 0.2% Aqua 75% & Hydrolyzed wheat protein/PVP crosspolymer 25% 30% Amodimethicone 20% & C1115 Pareth-7 & Laureth-9 & Glycerin & Trideceth-12
ChemLin 0.1 k Surfache 0.1 m Schulke 0.045 & Mayr
NH
N
NEVER Croda
N
1987
R43; R51/53
2119
HAZ
NH
FUNCTION
Protein
T Conditioner mist/spray; R41; R38
AD AT
Goldsch 0.5
0.5
GE 0.5 Silicones
Fragranc 0.5 e Oils
2213
Perfume Vibrant Days 157108
Parfum
Fragrance (Parfum)
1817
Seamoss/Seacare
N
NEVER Adina
0.2
Cremophor RH40
Water (Aqua) 50.5% & Propylene Glycol 49% NH & Chondrus Crispus (Carrageenan) extract 0.5% PEG-40 hydrogenated castor oil NH
Natural
0419
Aqua 50.5% & Propylene Glycol 49% & Chondrus Crispus (Carrageenan) extract 0.5% PEG-40 hydrogenated castor oil
Emulsifier
N
0.5
0288
Purified Water
Aqua
Water (Aqua)
Solvent
1998 DT Basf Chem Law UPL
NH
Fragrance
46.655 100
9.8 0.007 0.000175 0.00007 0.00035 0.0077
0.1 0.1 0.009 0.000225 0.00009 0.375 0.125 0.1 0.0125 0.0125 0.0125 0.0125 0.5 0.101 0.098 0.001 0.5
28 July 2003 DP1177D; UD9935; UD10294 21 November 2003 Euxyl Mg salts added
This Product Information Package is presented in accordance with Article 7a of Council Directive 93/35/EEC amending for the 6th time Directive 76/768/EEC on the approximation of the laws of Member States relating to cosmetic products.
UNIVERSAL PRODUCTS LIMITED PRODUCT INFORMATION PACKAGE PRODUCT: ANDREW JOSE JLIFE CATCH A WAVE CURL DEFINING SHAMPOO PRODUCT CODE: UM0362 Date: Prepared By:
MANUFACTURING FORMULA
PRODUCT: ANDREW JOSE JLIFE CATCH A WAVE CURL DEFINING SHAMPOO PRODUCT CODE: UM0362
RM
TRADE NAME
INCI - HARM
1310
SLES 28% Euxyl preserved (0.1%); Steol CS230-E
9.8 0.007 0.000175 0.00007 0.00035 0.0077
0997
Tegobetaine F50
Sodium laureth sulfate 28% & Benzyl alcohol 35 (0.02%) & Methylchloroisothiazolinone(0.0005%) & Methylisothiazolinone (0.0002) Magnesium chloride 0.001% & Magnesium nitrate 0.022% Cocamidopropyl betaine 36% 12
0142
Salt PVD
Sodium chloride
1
1454
Lamesoft PO65
Coco-glucoside 30% & Glyceryl oleate 30% 2
0713
Abil 9950
Dimethicone propyl PG-betaine 30%
0.5
0.6 0.6 0.15
0182
D-Panthenol
Panthenol
0.2
0.2
0111
Vitamin E Acetate
Tocopheryl acetate
0.2
0.2
0393
Allantoin
Allantoin
0.1
0.1
0207
Tetrasodium EDTA
Tetrasodium EDTA
0.1
0.1
0714
Euxyl K100
1780
Hydrotriticum PVP 25/75 Silicone SME 253
Benzyl alcohol 20% & 0.045 Methylchloroisothiazolinone 0.5% & Methylisothiazolinone 0.2% Water (Aqua) 75% & Hydrolyzed wheat 0.5 protein/PVP crosspolymer 25% 30% Amodimethicone 20% & C11-15 Pareth- 0.5 7 & Laureth-9 & Glycerin & Trideceth-12
2119
WT%
1
0.5
2213
Perfume Vibrant Days 157108
Parfum
1817
Seamoss/Seacare
0419
Cremophor RH40
Water (Aqua) 50.5% & Propylene Glycol 49% 0.2 & Chondrus Crispus (Carrageenan) extract 0.5% PEG-40 hydrogenated castor oil 0.5
0288
Purified Water
Water (Aqua)
46.655 100
28 July 2003 DP1177D; UD9935; UD10294 21 November 2003 Euxyl Mg salts added
WT% ACT
4.32
0.009 0.000225 0.00009 0.375 0.125 0.1 0.0125 0.0125 0.0125 0.0125 0.5 0.101 0.098 0.001 0.5
PRODUCT COMPOSITION - INGREDIENT LIST PRODUCT: ANDREW JOSE JLIFE CATCH A WAVE CURL DEFINING SHAMPOO PRODUCT CODE: UM0362 INCI - HARM Water (Aqua) Sodium laureth sulfate Cocamidopropyl betaine Sodium chloride * Coco-glucoside Glyceryl oleate Fragrance (Parfum) PEG-40 hydrogenated castor oil Panthenol Tocopheryl acetate Dimethicone propyl PG-betaine Hydrolyzed wheat protein/PVP crosspolymer Amodimethicone Allantoin Tetrasodium EDTA Propylene Glycol Benzyl alcohol Glycerin C11-15 Pareth-7 Laureth-9 Trideceth-12 Magnesium nitrate Chondrus Crispus (Carrageenan) extract Methylchloroisothiazolinone Magnesium chloride Methylisothiazolinone
SENSITISERS Hexyl cinnamal Hydroxyisohexyl 3-cyclohexene carboxaldehyde Limonene Linalool
28 July 2003 DP1177D; UD9935 21 November 2003 Euxyl Mg salts added
WT% ACT 81.53139 9.8 4.32 1 0.6 0.6 0.5 0.5 0.2 0.2 0.15 0.125 0.1 0.1 0.1 0.098 0.016 0.0125 0.0125 0.0125 0.0125 0.0077 0.001 0.0004 0.00035 0.00016 100 % 0.0214 0.0143 0.0116 0.0168
PRODUCT: ANDREW JOSE JLIFE CATCH A WAVE CURL DEFINING SHAMPOO PRODUCT CODE: UM0362
INCI - HARM
Water (Aqua) Sodium laureth sulfate Cocamidopropyl betaine Sodium chloride * Chondrus Crispus (Carrageenan) extract Panthenol Tocopheryl acetate Allantoin Glycerin Hydrolyzed wheat protein/PVP crosspolymer Coco-glucoside Glyceryl oleate Fragrance (Parfum) Amodimethicone Dimethicone propyl PG-betaine PEG-40 hydrogenated castor oil C11-15 Pareth-7 Laureth-9 Trideceth-12 Hexyl cinammal Hydroxyisohexyl 3-cyclohexene carboxaldehyde Limonene Linalool Tetrasodium EDTA Propylene glycol Magnesium chloride Magnesium nitrate Benzyl alcohol Methylchloroisothiazolinone Methylisothiazolinone
PAO = 18M
28 July 2003 DP1177D; UD9935 18 August 2003 Perf Sensitisers added 21 November 2003 Euxyl Mg salts added 28 June 2004 PAO added
RAW MATERIAL SPECIFICATIONS PRODUCT: ANDREW JOSE JLIFE CATCH A WAVE CURL DEFINING SHAMPOO PRODUCT CODE: UM0362
Conform to the requirements of relevant legislation currently in force in the UK and to good manufacturing practice
FINISHED PRODUCT SPECIFICATION
PRODUCT: ANDREW JOSE JLIFE CATCH A WAVE CURL DEFINING SHAMPOO PRODUCT CODE: UM0362
Description Odour pH Viscosity Total Solids Weight per ml Microbial Checks
26 February 2004
SPECIFICATION A clear, pale straw, viscous liquid. Characteristic. 5.00 - 6.00 at 25º C 5 000 -7 000 at 25º C, using spindle 3 @ 10 rpm. TBR at 20º C for first 5 batches. TBR at 20º C for first 5 batches. TVC Bacteria <100 cfu/g TVC Yeasts and Moulds <100 cfu/g
TEST METHOD LPM0089
TL003 TL004 TL007 TL295 TM006 TM006
PERSON RESPONSIBLE FOR MANUFACTURE
This product was manufactured according to the principles of Good Manufacturing Practice (Ref COLIPA GMP Guidelines). The person responsible for the manufacture of this product is:Production Manager Universal Products Ltd. Bradshaw Lane, Greenhalgh, Kirkham, Preston,Lancs PR4 3JA
PRODUCT: ANDREW JOSE JLIFE CATCH A WAVE CURL DEFINING SHAMPOO PRODUCT CODE: UM0362
METHOD OF MANUFACTURE 1. Add the ingredients with mixing until thoroughly dispersed 2. Submit sample to QC Laboratory for testing.
. 26 February 2004
SAFETY ASSESSMENT SAFETY ASSESSOR
David Hilton Universal Products Ltd
PRODUCT: ANDREW JOSE JLIFE CATCH A WAVE CURL DEFINING SHAMPOO PRODUCT CODE: UM0362
Following review of the information provided for the above product and its ingredients, the product is considered acceptable for the intended application. The assessment was based on the chemical specification and toxicological profile of the ingredients, including perfume, together with the toxicological profile of the complete product. As a result of this assessment it is concluded that the product will not cause damage to human health when applied under normal or reasonably foreseeable conditions of use. This safety assessment for human health is based upon information available at this date. Reviews of this assessment will be made as and when new information becomes available. This assessment constitutes formal notification of safety required by European Union Council under directive 93/35 EEC.
Signature:………………….
Date:………………..
Safety Assessor : David Hilton CChem MRSC Technical Director Universal Products Ltd Fairfield, Bradshaw Lane Greenhalgh, Kirkham, Preston, Lancs. PR4 3JA
UNDESIRABLE EFFECTS ON HUMAN HEALTH PRODUCT: ANDREW JOSE JLIFE CATCH A WAVE CURL DEFINING SHAMPOO PRODUCT CODE: UM0362
Total Number of professionally substantiated undesirable health effects since launch date = None reported to UPL CASE NUMBER
DATE
PROOF OF EFFECT CLAIMED
PRODUCT: ANDREW JOSE JLIFE CATCH A WAVE CURL DEFINING SHAMPOO PRODUCT CODE: UM0362
ASSESSMENT OF SAFETY FOR HEALTH PRODUCT: ANDREW JOSE JLIFE CATCH A WAVE CURL DEFINING SHAMPOO PRODUCT CODE: UM0362
1. Legislation This document addresses the requirement of the EU for an "assessment of safety for human health" of finished cosmetic products (Directive 93/35/EEC, Article 7a, subsection 1d) by considering the general toxicological profile of the ingredients and an assessment of the final product. 2. Company Policy The product and its ingredients have also been assessed to ensure compliance with company policy requirements for product safety assessment. 3. Product Composition Company policy requires that, at the least, cosmetic grade materials (where available) are used. dl-alpha-Tocopheryl Acetate
Vitamin E Acetate
RM:0111
Obtained by vacuum steam distillation and acetylation of edible vegetable oil products, dlalpha-Tocopheryl Acetate serves as an antioxidant and Vitamin E source in cosmetics and pharmaceuticals as well as a skin moisturiser and a free radical scavenger. It is also a permitted nutrient in dietary supplements. A CIR Expert , on reviewing toxicity data, has concluded that it is safe to use as a cosmetic ingredient up to levels of 36% for all cosmetic products, including this one. Clinical studies have shown that Tocopheryl Acetate is not an irritant or a sensitiser. Concern over lack of data on inhalation toxicity was allayed because of the low level, 0.0001-0.2%, used in hair sprays (CIR Final Report 9/99). It is also a permitted nutrient in dietary supplements. Sodium Chloride
Salt PVD
RM: 0142
Common salt is used as a viscosifier in cosmetics and a preservative, flavouring agent in foods and pharmaceuticals. Common salt or sodium chloride is considered by the US FDA as safe for its intended use as a food additive. This GRAS (generally recognised as safe) classification, and the universal use of sodium chloride since antiquity, affirms its safety. The Merck Index refers to sodium chloride as "not generally considered poisonous." It is an eye and skin irritant. The data and widespread use the level and use in this product.
Panthenol
D-Panthenol
RM: 0182
Panthenol (Pro Vitamin B5) is the alcohol analogue of Pantothenic Acid (Vitamin B3) and has been widely used up to a maximum level (Frame Formulation) of 10% as a conditioning agent for hair and skin for many years. It is also used as a food additive. A CTFA Cosmetic Ingredient Review Expert has reviewed the toxicity of Panthenol and considered it safe to use up to levels of 25% in this and all other cosmetic products. (JACT 6 (1) 139-62, 1987). Tetrasodium EDTA
40% Tetrasodium EDTA
RM 0207
The tetrasodium salt of ethylenediamine tetracetic acid is used as a sequestrant and chelating agent in a wide range of applications, and usually at concentrations below 2% in cosmetics. A CIR Expert , on reviewing toxicity data, has concluded that it is safe to use as a cosmetic ingredient up to levels of 1% for applications in cosmetic products. It enhances the penetration of some compounds as it chelates calcium, and thus disrupts intercellular bridging. This should be taken into when formulating ingredients designated as safe primarily because they are not significantly absorbed. Concerns over inhaled formulations were alleviated as the maximum dose was below that which produced reproductive or developmental toxicity. (Final Report (12) 1999). It is a significant eye and skin irritant. Tetrasodium EDTA is FDA approved for injectables, inhalants, ophthalmics, orals and topicals. The data the level and use in this product. Allantoin
RM: 0393
This heterocycluc organic compound occurs widely in the animal and vegetable kingdom as the active principle of comfrey root and the metabolic end-product in lower animals and has been used for many years in the medical field for treatment of skin disorders. More recently it has been used in the cosmetic field, due to its keratolytic properties, in a wide variety of creams and lotions, at levels of 0.1 - 0.5%. It is FDA approved as a Category I (safe and effective) skin protectant. The non-toxic, non-irritant, non-allergenic, non-sensitizing nature of Allantoin, together with the fact that no adverse effects have been reported in its topical use, justify the use and level of it in this product. PEG-40 Hydrogenated Castor Oil
Cremophor RH40
RM 0419
This polyethylene glycol derivative of hydrogenated castor oil is used as an emulsifying or solubilising agent in a wide variety of cosmetic products, typically at concentrations up to 5%. It is also used in a range of pharmaceutical forms and in food- applications. A CTFA Cosmetic Ingredient Review Expert has reviewed the toxicity of PEG-40 Hydrogenated Castor Oil and considered it safe for use in this and all other cosmetic products at a concentration of 100% (IJT 16(S1), 269 - 306, 1997). Dimethicone propyl PG-betaine
30% Abil 9950
RM 0713
A surfactant and conditioner in hair and skin products dimethicone propyl PG-betaine is used at concentrations 0.5 - 5%. Animal tests show it has low acute toxicity, very slight skin irritancy and its non-irritancy to eyes, combined with the manufacturers statement that no adverse effects have been observed or reported justify its use and level in the this product.
Benzyl Alcohol
20%
Euxyl K100
RM 0714
Benzyl Alcohol is an aromatic alcohol used as a preservative, solvent and perfumery component in cosmetics. A CTFA Cosmetic Ingredient Review Expert has reviewed the toxicity of Benzyl Alcohol and concluded that it can be safely used in cosmetic formulations up to 5%, and up to 10% in hair dyes; whereas there was insufficient data to its use in products which are inhaled. (IJT 20(S3), 23 - 50, 2001). The Cosmetic Products (Safety) Regulations 2003 limit its use as a preservative to a maximum concentration of 1% in this and all other cosmetic products; when used as a solvent or in perfumes there is no maximum limit. The 7th Amendment 2003/15/EC to Council Directive 76/768/EEC, to be adopted before September 2004 requires the inclusion of Benzyl alcohol (because of its likelihood of causing allergenic reactions) in the list of ingredients when its concentration exceeds 0.001% in leaveon products and 0.01% in rinse-off products. The data the level and use of Benzyl Alcohol in this product.
Methylchloroisothiazolinone Methylisothiazolinone
0.5% Euxyl K100 0.2% Euxyl K100
RM 0714 RM 0714
Methylisothiazolinone and Methylchloroisothiazolinone are heterocyclic organic compounds used in cosmetics as a broad spectrum preservative system. A CTFA Cosmetic Ingredient Review Expert has reviewed the toxicity of Methylisothiazolinone and Methylchloroisothiazolinone and concluded that they may be safely used at a concentration not exceeding 15 ppm in rinse-off products and at a concentration not to exceed 7.5 ppm in leave-on cosmetic products. This safe use refers to a mixture containing 23.3% Methylisothiazolinone and 76.7% Methylchloroisothiazolinone. (JACT 11(1), 75 - 128, 1992). The Cosmetic Products (Safety) Regulations 1996 limit their use as a preservative to a maximum concentration of 0.0015% of a mixture in the ratio 3:1 of Methylchloroisothiazolinone to Methylisothiazolinone in all cosmetic products. The data the level and use of Methylchloroisothiazolinone to Methylisothiazolinone in this product. Cocamidopropyl betaine
Tegobetain F50
RM: 0997
This zwitterionic ammonium compound is used as an amphoteric surfactant and thickener at levels up to 1% for hair, shower and bath preparations and for pharmaceuticals; it is an antiirritant for anionic surfactants. A CTFA Cosmetic Ingredient Review Expert has reviewed the toxicity of Cocamidopropyl Betaine and concluded it is safe for use in rinse-off products; whereas for leave-on products the concentration should not exceed 3%., due to its irritation potential (JACT, 10(1), 1991). Reports of skin sensitization in humans is considered to be due to the presence of unreacted starting materials. The data the level and use in this product. Sodium Laureth Sulfate
28% SLES 28%
RM: 1310
Sodium Laureth Sulfate is an anionic surfactant, widely used in detergents and personal care products. A CTFA Cosmetic Ingredient Review Expert has reviewed the toxicity of Sodium Laureth Sulfate , and concluded that it is safe as presently used in this and other cosmetic products at concentrations exceeding 50%, though recognising that its use may result in eye and skin irritation. (JACT 2 (5) 1 - 34, 1983). Sodium Laureth Sulfate is also approved by the US FDA for topicals and for food applications. The data the level and use in this product.
Coco-glucoside 30% Glyceryl Oleate 30%
Lamesoft PO65
RM: 1454
A lipid layer enhancer for surfactant cleansers, Lamesoft is used as a viscosity builder in shower gels, foam baths, hair shampoos and baby products. It is a severe eye irritant, and a slight irritant to the skin and mucous membranes. The level and use in this product can be judged as safe. Coco-glucoside
30% Lamesoft PO65
RM: 1454
This non-ionic surfactant, the condensation product of coconut alcohol with glucose, with dermatological properties is also used as a foam control agent in cosmetics and as an emulsifier in dermopharmaceuticals. It has no known toxicity, but is a skin and eye irritant. The level and use in this product can be judged as safe. Glyceryl Oleate
30% Lamesoft PO65
RM: 1454
The monoester of glycerin and oleic acid, Glyceryl Oleate is used as an emollient, emulsifier, thickener and opacifier in cosmetics, at concentrations up to 5%. It is FDA approved for oral pharmaceuticals and amongst many other applications is used in food and food- products. A CTFA Cosmetic Ingredient Review Expert has reviewed the toxicity of Glyceryl Oleate and considered it safe to use up to levels of 5% in this and all cosmetic products. (JACT 5(5), 391 - 413, 1986). Animal studies showed no oral toxicity, minimal to severe dermal irritation, and minimal to moderate eye irritation. Formulations containing 5% Glyceryl oleate were non irritating and non-phototoxic in human tests. The level and use in this product can be judged as safe. Hydrolyzed wheat protein/PVP crosspolymer 25% Hydrotriticum PVP 25/75 RM: 1780
This hydrolyzed wheat protein/polyvinylpyrrolidone complex is used as a conditioner and film former for hair and skin products, where its use is recommended at 1-5%. The manufacturers expect it to be non-toxic by oral and dermal routes and a non-irritant to eyes and skins. There is limited toxicological available on the complex but the hydrolysed wheat protein moiety is considered to be non-toxic. A CIR review has reviewed the toxicity of both PVP and a PVP/VA copolymer and considered them to be safe as cosmetic ingredients, at levels of up to 35% for the former and greater than 50% for the copolymer; with animal studies showing them to be non-toxic, non-irritant to eyes and skin and non-skin sensitising, the latter being confirmed also in human studies. (IJT (S4) 95-130, 1998; JACT 2(5) 141-159, 1983). The data justify the level and use in this product. Aqua 49% Sea Care Propylene glycol 49% Chondrus Crispus (Carrageenan) extract 1%
RM1817
The hydroglycolic extract of red seaweed, Chondrus Crispus (Carrageenan), is used as a moisturiser and conditioner at a recommended level of 3% in hair and skin care products. Non- irritant to the eyes and skin, there is very limited toxicological data available, with much of the toxicological studies on seaweeds concentrating on the suspected potential of phycocyanin found in blue-green algae of being allergenic and of causing dermatitis. The limited data and very low level of use in this product justifies its safe use.
Chondrus Crispus (Carrageenan) extract
0.5% Sea Care
RM1817
The red algae Chondrus Crispus (Carrageenan) is used as an emollient in cosmetics and as a thickening agent, binder and gellant in food, cosmetics and pharmaceuticals at 1-5%. It is FDA approved for use in orals and topicals; and is approved for use in Japan. Concerns about the posssible promotion of colon cancer have been alleviated by a t FAO/WHO Committee who after reviewing all the toxicology and carcinogenic studies on Carrageenan has classified Carrageenan as a food additive ADI (acceptable daily intake) "not specified", the most favourable ADI for a food additive. The data justify the level and use in this product.
Propylene glycol
49% Sea Care
RM1817
An aliphatic dihydric alcohol, propylene glycol is used as an extractant, solvent, conditioning agent and humectant in thousands of cosmetic formulations. A CTFA Cosmetic Ingredient Review Expert has reviewed the toxicity of Propylene Glycol and considered it safe to use up to levels of 50% in this and other cosmetic products (JACT 6 (1); 23-51, 1987). The imposition of an upper limit was considered necessary because of the potential for skin irritancy and sensitization. It is also used in food applications and as a solvent in pharmaceutical preparations. In the US it is FDA approved for orals, parenterals, topicals and it is approved with limitations in Japan. Amodimethicone 20% C11-15 Pareth-7 Laureth-9 Glycerin Trideceth-12
30% Silicone SME 253
RM: 2119
This microemulsion of aminopropylaminoethyl polysiloxane, containing C11-15 pareth-7, laureth-9, glycerin and trideceth-12, is used in rinse-off conditioners. The manufacturer states that all components comply with regulations related to personal care products in the US, EU Canada, Japan, Korea and China. It is a skin irritant and may cause serious damage to eyes. Aerosols have a high potential for inhalation toxicity, and exposure must be avoided when spraying alone or in mixtures.
Amodimethicone
20% Silicone SME 253
RM: 2119
The silicone polymer end-blocked with amino functional groups is used as a hair conditioning agent at concentrations up to 15%. A CTFA Cosmetic Ingredient Review Expert has reviewed the toxicity of Amodimethicone and considered it to be safe as a cosmetic ingredient at a maximum concentration of up to 3% (CIR Final Report 2/00). The considered that it would not be significantly absorbed into the skin because of its large molecular weight. Concerns over inhalation were alleviated as manufacturing processes for cosmetic formulations produce particle size distributions that are not significantly respirable. The data justify the use and level in this product. C11-15 Pareth-7
Silicone SME 253
RM: 2119
A linear alkyl ethoxylate C11-15 Pareth-7 is used as a non-ionic surfactant and emulsifier in cosmetics and in the manufacture of food articles. The data the low level and use in this product.
Glycerin
Silicone SME 253
RM: 2119
The polyhydric alcohol, glycerin, has a long history of use as an emollient and conditioning agent in cosmetic products at maximum levels of 50%. It is also used as an active ingredient in external and internal drug products and is a permitted food additive. It is FDA approved for ophthalmics, orals, parenterals, dentifrices, imtermuscular injectables and rectals. Glycerol is safe for us in this product.
Laureth-9
Silicone SME 253
RM: 2119
The PEG ether of lauryl alcohol, Laureth-9 is a non-ionic emulsifier which is also used in food and packing materials, as a spermicide and in the treatment of vein disorders. It has a low order of toxicity and is non-volatile. The data and its low level justify its use in this product. Trideceth-12
Silicone SME 253
RM: 2119
The PEG ether of tridecyl alcohol, Trideceth-12 is a non-ionic emulsifier and surfactant in cosmetics, which is also used as a defoamer in food and packing materials. There is limted toxicological data available but its very low level justifies its use in this product. Parfume Fragrance Vibrant Days 157108
Fragrance Oils
RM2213
The perfume complies with IFRA guidelines, and a safety evaluation has been undertaken. 4. Assessment of safety for human health and the finished product. The shampoo is based on conventional cosmetic ingredients for this type of product. Similar formulations have been marketed for many years without significant adverse effects. This shampoo is not considered to represent any undue hazards with respect to human health in normal use and under reasonably foreseeable misuse
Prepared By:……………
Date:……………
MATERIAL SAFETY DATA SHEET 1 IDENTIFICATION OF SUBSTANCE/PREPARATION AND COMPANY PRODUCT: ANDREW JOSE JLIFE CATCH A WAVE CURL DEFINING SHAMPOO PRODUCT CODE: UM0362 Company Identification:
Universal Products Manufacturing Ltd. Fairfield Bradshaw Lane Greenhalgh Kirkham Preston Lancashire PR4 3JA
Emergency Telephone:
01772 685777 (Mon - Fri 8.00 - 6.00) Technical Director 01772 725186 - all other times
2. COMPOSITION/INFORMATION AND INGREDIENTS
Hazardous Ingredients: Substance Sodium laureth sulfate Cocamidopropyl betaine
Concn 9.8 wt% 4.32 wt%
Hazard Xi Xi
R phrases R36/38 R36
3. HAZARDS IDENTIFICATION Health Hazards:
Non-hazardous..
4. FIRST AID MEASURES Ingestion: Rinse mouth with water. Give milk or water to drink. Obtain medical advice. Inhalation:
Not applicable.
Skin : Not applicable Eye :
Immediately rinse eyes with plenty of water. Remove any lenses. If tissue damage or persistent irritation is apparent, obtain medical advice immediately.
5. FIRE FIGHTING MEASURES Extinguishing Media:
C02, dry chemical, chemical foam, water spray or mist (not water jet).
Special Exposure Hazards: Special Protective Equipmen:
Halogen and nitrogen decomposition products expected. Self-contained breathing apparatus or supplied-air breathing apparatus may be required.
6. ACCIDENTAL RELEASE MEASURES Personal Precautions: Not applicable. Environmental Precautions: No specific precautions advised. Methods of Cleaning: Absorb the material onto porous, inert material, such as sand, earth etc and dispose of in accordance with local regulations. 7. HANDLING AND STORAGE Storage Conditions:
Store indoors at constant temperature, preferably around 150C. Keep away from oxidising agents.
General Handling Precautions: Handle in accordance with good occupational hygiene and safety practices. Avoid with skin and eyes. Do not ingest undiluted material. 8. EXPOSURE CONTROLS/PERSONAL PROTECTION Exposure Controls: Personal Protection:
Not applicable If excessive exposure is anticipated the following protection measures should be taken: Hand protection: Disposable/rubber gloves. Skin protection: Overalls with protection to arms.
9. PHYSICAL AND CHEMICAL PROPERTIES Appearance: Odour pH: Boiling Point: Melting Point: Flash Point: Flammability (Solid Gas): Explosive Properties: Oxidising Properties: Wt/ml @ 200C: Solubility: Partition Coefficient Refractive Index
A clear, pale straw, viscous liquid. Characteristic. 5.00 - 6.00 at 25ºC N/A. N/A. >100°C. N/A. Non-explosive. Non-oxidiser. Not determined. Water dispersible. Not determined. Not determined.
10. STABILITY AND REACTIVITY Stability:
Stable under normal conditions.
Materials to Avoid:
Strong oxidising materials.
11. TOXICOLOGICAL INFORMATION Not hazardous.
12. ECOLOGICAL INFORMATION None available. 13. DISPOSAL CONSIDERATIONS Disposal should be according to local authority regulations. Not a special waste. 14. TRANSPORT INFORMATION UN Number: Not classified under UN Transport Regulations. 15. REGULATORY INFORMATION Non-hazardous.
16. OTHER INFORMATION Nil
Date of Issue…26 February 2004 Issue No:…1…. This Safety Data Sheet has been prepared in order to assist s to perform their own assessment of the requirements for safe handling under the Control of Substances Hazardous to Health Regulations and similar legislation. The information provided in this MSDS is correct to the best of our knowledge, information and belief at the date of its publication, and is, in our opinion consistent with the state of general scientific and technical knowledge at that date, but we cannot accept liability for loss, injury or damage which may result from its use. We must point out that it is the responsibility of any intermediate supplier to ensure that the information contained in this MSDS is ed to the ultimate . If any such ultimate wishes to make arrangements for versions to be sent directly to him, we shall if so notified, be glad to make the necessary entry in our records.
STABILITY TESTING SUMMARY
PRODUCT: ANDREW JOSE JLIFE CATCH A WAVE CURL DEFINING SHAMPOO PRODUCT CODE: UM0362
PACKAGING: 150 ml glass wide neck jar. TEMPERATURES: 5° C, 25° C, 35° C and 45° C. INTERVALS: 1week, 1month, 3, 6, 12, and 24 months.
TESTS PERFORMED
SPECIFICATION
TEST METHOD
CONCLUSIONS: Product fulfils all required criteria, up to and including 24 months.
Prepared By:_______________________________
Approved By:_______________________________
DATE:
RESULT
TRADE NAME
0111
Vitamin E Acetate
0142
Salt PVD
0182
D-Panthenol
0207
Tetrasodium EDTA
0288
Purified Water
0393
Allantoin
0419
Cremophor RH40
0713
Abil 9950
0714
Euxyl K100
0997
Tegobetaine F50
1310
SLES 28% Euxyl preserved (0.1%); Steol CS230-E
1454
Lamesoft PO65
1780
Hydrotriticum PVP 25/75
1817
Seamoss/Seacare
2119
Silicone SME 253
2213
Perfume Vibrant Days 157108
28 July 2003 DP1177D; UD9935; UD10294 21 November 2003 Euxyl Mg salts added
RM INFO PRODUCT: ANDREW JOSE JLIFE CATCH A WAVE CURL DEFINING SHAMPOO PRODUCT CODE: UM0362 RM
TRADE NAME
INCI
INCI - HARM
WT% ACT
Surfactant
SUPPLIE WT% R 35 NEVER Stepan
1310
SLES 28% Euxyl preserved (0.1%); Steol CS230-E
0997
Tegobetaine F50
Sodium laureth sulfate 28% & Benzyl alcohol (0.02%) & Methylchloroisothiazolinone(0.0005 %) & Methylisothiazolinone & Magnesium chloride 0.001% & Magnesium nitrate 0.022% Cocamidopropyl betaine 36%
Sodium laureth sulfate 28% & Benzyl alcohol R36/38 (0.02%) & Methylchloroisothiazolinone(0.0005%) & Methylisothiazolinone (0.0002) Magnesium chloride 0.001% & Magnesium nitrate 0.022% Cocamidopropyl betaine 36% R36
Antistat; Cond N
NEVER Goldsch 12
4.32
0142
Salt PVD
Sodium chloride
Sodium chloride
Viscosifier
N
NEVER NCS
1
1
1454
Lamesoft PO65
Surfactant
N
NEVER Cognis
2
Abil 9950
Coco-glucoside 30% & Glyceryl Coco-glucoside 30% & Glyceryl oleate 30% R41; oleate 30% R36/38 Dimethicone propyl PG-betaine 30% Dimethicone propyl PG-betaine 30% NH
Conditioner
N
1985
0.6 0.6 0.15
0713 0182
D-Panthenol
Panthenol
Panthenol
NH
Moisturiser
N
1998 DT Basf
0.2
0.2
0111
Vitamin E Acetate
Tocopheryl acetate
Tocopheryl acetate
NH
Moisturiser
N
1989
Basf
0.2
0.2
0393
Allantoin
Allantoin
Allantoin
NH
Skin Cond.
N
1985
0207
Tetrasodium EDTA
Tetrasodium EDTA
Tetrasodium EDTA
R36/38
Chelant
N
1980
0714
Euxyl K100
N
1985
Hydrotriticum PVP 25/75 Silicone SME 253
Benzyl alcohol 20% & Methylchloroisothiazolinone 0.5% & Methylisothiazolinone 0.2% Water (Aqua) 75% & Hydrolyzed wheat protein/PVP crosspolymer 25% 30% Amodimethicone 20% & C11-15 Pareth7 & Laureth-9 & Glycerin & Trideceth-12
R34; R43; Preservative R52/53
1780
Benzyl alcohol 20% & Methylchloroisothiazolinone0.5% & Methylisothiazolinone 0.2% Aqua 75% & Hydrolyzed wheat protein/PVP crosspolymer 25% 30% Amodimethicone 20% & C1115 Pareth-7 & Laureth-9 & Glycerin & Trideceth-12
ChemLin 0.1 k Surfache 0.1 m Schulke 0.045 & Mayr
NH
N
NEVER Croda
N
1987
R43; R51/53
2119
HAZ
NH
FUNCTION
Protein
T Conditioner mist/spray; R41; R38
AD AT
Goldsch 0.5
0.5
GE 0.5 Silicones
Fragranc 0.5 e Oils
2213
Perfume Vibrant Days 157108
Parfum
Fragrance (Parfum)
1817
Seamoss/Seacare
N
NEVER Adina
0.2
Cremophor RH40
Water (Aqua) 50.5% & Propylene Glycol 49% NH & Chondrus Crispus (Carrageenan) extract 0.5% PEG-40 hydrogenated castor oil NH
Natural
0419
Aqua 50.5% & Propylene Glycol 49% & Chondrus Crispus (Carrageenan) extract 0.5% PEG-40 hydrogenated castor oil
Emulsifier
N
0.5
0288
Purified Water
Aqua
Water (Aqua)
Solvent
1998 DT Basf Chem Law UPL
NH
Fragrance
46.655 100
9.8 0.007 0.000175 0.00007 0.00035 0.0077
0.1 0.1 0.009 0.000225 0.00009 0.375 0.125 0.1 0.0125 0.0125 0.0125 0.0125 0.5 0.101 0.098 0.001 0.5
28 July 2003 DP1177D; UD9935; UD10294 21 November 2003 Euxyl Mg salts added
This Product Information Package is presented in accordance with Article 7a of Council Directive 93/35/EEC amending for the 6th time Directive 76/768/EEC on the approximation of the laws of Member States relating to cosmetic products.
UNIVERSAL PRODUCTS LIMITED PRODUCT INFORMATION PACKAGE PRODUCT: ANDREW JOSE JLIFE CATCH A WAVE CURL DEFINING SHAMPOO PRODUCT CODE: UM0362 Date: Prepared By:
MANUFACTURING FORMULA
PRODUCT: ANDREW JOSE JLIFE CATCH A WAVE CURL DEFINING SHAMPOO PRODUCT CODE: UM0362
RM
TRADE NAME
INCI - HARM
1310
SLES 28% Euxyl preserved (0.1%); Steol CS230-E
9.8 0.007 0.000175 0.00007 0.00035 0.0077
0997
Tegobetaine F50
Sodium laureth sulfate 28% & Benzyl alcohol 35 (0.02%) & Methylchloroisothiazolinone(0.0005%) & Methylisothiazolinone (0.0002) Magnesium chloride 0.001% & Magnesium nitrate 0.022% Cocamidopropyl betaine 36% 12
0142
Salt PVD
Sodium chloride
1
1454
Lamesoft PO65
Coco-glucoside 30% & Glyceryl oleate 30% 2
0713
Abil 9950
Dimethicone propyl PG-betaine 30%
0.5
0.6 0.6 0.15
0182
D-Panthenol
Panthenol
0.2
0.2
0111
Vitamin E Acetate
Tocopheryl acetate
0.2
0.2
0393
Allantoin
Allantoin
0.1
0.1
0207
Tetrasodium EDTA
Tetrasodium EDTA
0.1
0.1
0714
Euxyl K100
1780
Hydrotriticum PVP 25/75 Silicone SME 253
Benzyl alcohol 20% & 0.045 Methylchloroisothiazolinone 0.5% & Methylisothiazolinone 0.2% Water (Aqua) 75% & Hydrolyzed wheat 0.5 protein/PVP crosspolymer 25% 30% Amodimethicone 20% & C11-15 Pareth- 0.5 7 & Laureth-9 & Glycerin & Trideceth-12
2119
WT%
1
0.5
2213
Perfume Vibrant Days 157108
Parfum
1817
Seamoss/Seacare
0419
Cremophor RH40
Water (Aqua) 50.5% & Propylene Glycol 49% 0.2 & Chondrus Crispus (Carrageenan) extract 0.5% PEG-40 hydrogenated castor oil 0.5
0288
Purified Water
Water (Aqua)
46.655 100
28 July 2003 DP1177D; UD9935; UD10294 21 November 2003 Euxyl Mg salts added
WT% ACT
4.32
0.009 0.000225 0.00009 0.375 0.125 0.1 0.0125 0.0125 0.0125 0.0125 0.5 0.101 0.098 0.001 0.5
PRODUCT COMPOSITION - INGREDIENT LIST PRODUCT: ANDREW JOSE JLIFE CATCH A WAVE CURL DEFINING SHAMPOO PRODUCT CODE: UM0362 INCI - HARM Water (Aqua) Sodium laureth sulfate Cocamidopropyl betaine Sodium chloride * Coco-glucoside Glyceryl oleate Fragrance (Parfum) PEG-40 hydrogenated castor oil Panthenol Tocopheryl acetate Dimethicone propyl PG-betaine Hydrolyzed wheat protein/PVP crosspolymer Amodimethicone Allantoin Tetrasodium EDTA Propylene Glycol Benzyl alcohol Glycerin C11-15 Pareth-7 Laureth-9 Trideceth-12 Magnesium nitrate Chondrus Crispus (Carrageenan) extract Methylchloroisothiazolinone Magnesium chloride Methylisothiazolinone
SENSITISERS Hexyl cinnamal Hydroxyisohexyl 3-cyclohexene carboxaldehyde Limonene Linalool
28 July 2003 DP1177D; UD9935 21 November 2003 Euxyl Mg salts added
WT% ACT 81.53139 9.8 4.32 1 0.6 0.6 0.5 0.5 0.2 0.2 0.15 0.125 0.1 0.1 0.1 0.098 0.016 0.0125 0.0125 0.0125 0.0125 0.0077 0.001 0.0004 0.00035 0.00016 100 % 0.0214 0.0143 0.0116 0.0168
PRODUCT: ANDREW JOSE JLIFE CATCH A WAVE CURL DEFINING SHAMPOO PRODUCT CODE: UM0362
INCI - HARM
Water (Aqua) Sodium laureth sulfate Cocamidopropyl betaine Sodium chloride * Chondrus Crispus (Carrageenan) extract Panthenol Tocopheryl acetate Allantoin Glycerin Hydrolyzed wheat protein/PVP crosspolymer Coco-glucoside Glyceryl oleate Fragrance (Parfum) Amodimethicone Dimethicone propyl PG-betaine PEG-40 hydrogenated castor oil C11-15 Pareth-7 Laureth-9 Trideceth-12 Hexyl cinammal Hydroxyisohexyl 3-cyclohexene carboxaldehyde Limonene Linalool Tetrasodium EDTA Propylene glycol Magnesium chloride Magnesium nitrate Benzyl alcohol Methylchloroisothiazolinone Methylisothiazolinone
PAO = 18M
28 July 2003 DP1177D; UD9935 18 August 2003 Perf Sensitisers added 21 November 2003 Euxyl Mg salts added 28 June 2004 PAO added
RAW MATERIAL SPECIFICATIONS PRODUCT: ANDREW JOSE JLIFE CATCH A WAVE CURL DEFINING SHAMPOO PRODUCT CODE: UM0362
Conform to the requirements of relevant legislation currently in force in the UK and to good manufacturing practice
FINISHED PRODUCT SPECIFICATION
PRODUCT: ANDREW JOSE JLIFE CATCH A WAVE CURL DEFINING SHAMPOO PRODUCT CODE: UM0362
Description Odour pH Viscosity Total Solids Weight per ml Microbial Checks
26 February 2004
SPECIFICATION A clear, pale straw, viscous liquid. Characteristic. 5.00 - 6.00 at 25º C 5 000 -7 000 at 25º C, using spindle 3 @ 10 rpm. TBR at 20º C for first 5 batches. TBR at 20º C for first 5 batches. TVC Bacteria <100 cfu/g TVC Yeasts and Moulds <100 cfu/g
TEST METHOD LPM0089
TL003 TL004 TL007 TL295 TM006 TM006
PERSON RESPONSIBLE FOR MANUFACTURE
This product was manufactured according to the principles of Good Manufacturing Practice (Ref COLIPA GMP Guidelines). The person responsible for the manufacture of this product is:Production Manager Universal Products Ltd. Bradshaw Lane, Greenhalgh, Kirkham, Preston,Lancs PR4 3JA
PRODUCT: ANDREW JOSE JLIFE CATCH A WAVE CURL DEFINING SHAMPOO PRODUCT CODE: UM0362
METHOD OF MANUFACTURE 1. Add the ingredients with mixing until thoroughly dispersed 2. Submit sample to QC Laboratory for testing.
. 26 February 2004
SAFETY ASSESSMENT SAFETY ASSESSOR
David Hilton Universal Products Ltd
PRODUCT: ANDREW JOSE JLIFE CATCH A WAVE CURL DEFINING SHAMPOO PRODUCT CODE: UM0362
Following review of the information provided for the above product and its ingredients, the product is considered acceptable for the intended application. The assessment was based on the chemical specification and toxicological profile of the ingredients, including perfume, together with the toxicological profile of the complete product. As a result of this assessment it is concluded that the product will not cause damage to human health when applied under normal or reasonably foreseeable conditions of use. This safety assessment for human health is based upon information available at this date. Reviews of this assessment will be made as and when new information becomes available. This assessment constitutes formal notification of safety required by European Union Council under directive 93/35 EEC.
Signature:………………….
Date:………………..
Safety Assessor : David Hilton CChem MRSC Technical Director Universal Products Ltd Fairfield, Bradshaw Lane Greenhalgh, Kirkham, Preston, Lancs. PR4 3JA
UNDESIRABLE EFFECTS ON HUMAN HEALTH PRODUCT: ANDREW JOSE JLIFE CATCH A WAVE CURL DEFINING SHAMPOO PRODUCT CODE: UM0362
Total Number of professionally substantiated undesirable health effects since launch date = None reported to UPL CASE NUMBER
DATE
PROOF OF EFFECT CLAIMED
PRODUCT: ANDREW JOSE JLIFE CATCH A WAVE CURL DEFINING SHAMPOO PRODUCT CODE: UM0362
ASSESSMENT OF SAFETY FOR HEALTH PRODUCT: ANDREW JOSE JLIFE CATCH A WAVE CURL DEFINING SHAMPOO PRODUCT CODE: UM0362
1. Legislation This document addresses the requirement of the EU for an "assessment of safety for human health" of finished cosmetic products (Directive 93/35/EEC, Article 7a, subsection 1d) by considering the general toxicological profile of the ingredients and an assessment of the final product. 2. Company Policy The product and its ingredients have also been assessed to ensure compliance with company policy requirements for product safety assessment. 3. Product Composition Company policy requires that, at the least, cosmetic grade materials (where available) are used. dl-alpha-Tocopheryl Acetate
Vitamin E Acetate
RM:0111
Obtained by vacuum steam distillation and acetylation of edible vegetable oil products, dlalpha-Tocopheryl Acetate serves as an antioxidant and Vitamin E source in cosmetics and pharmaceuticals as well as a skin moisturiser and a free radical scavenger. It is also a permitted nutrient in dietary supplements. A CIR Expert , on reviewing toxicity data, has concluded that it is safe to use as a cosmetic ingredient up to levels of 36% for all cosmetic products, including this one. Clinical studies have shown that Tocopheryl Acetate is not an irritant or a sensitiser. Concern over lack of data on inhalation toxicity was allayed because of the low level, 0.0001-0.2%, used in hair sprays (CIR Final Report 9/99). It is also a permitted nutrient in dietary supplements. Sodium Chloride
Salt PVD
RM: 0142
Common salt is used as a viscosifier in cosmetics and a preservative, flavouring agent in foods and pharmaceuticals. Common salt or sodium chloride is considered by the US FDA as safe for its intended use as a food additive. This GRAS (generally recognised as safe) classification, and the universal use of sodium chloride since antiquity, affirms its safety. The Merck Index refers to sodium chloride as "not generally considered poisonous." It is an eye and skin irritant. The data and widespread use the level and use in this product.
Panthenol
D-Panthenol
RM: 0182
Panthenol (Pro Vitamin B5) is the alcohol analogue of Pantothenic Acid (Vitamin B3) and has been widely used up to a maximum level (Frame Formulation) of 10% as a conditioning agent for hair and skin for many years. It is also used as a food additive. A CTFA Cosmetic Ingredient Review Expert has reviewed the toxicity of Panthenol and considered it safe to use up to levels of 25% in this and all other cosmetic products. (JACT 6 (1) 139-62, 1987). Tetrasodium EDTA
40% Tetrasodium EDTA
RM 0207
The tetrasodium salt of ethylenediamine tetracetic acid is used as a sequestrant and chelating agent in a wide range of applications, and usually at concentrations below 2% in cosmetics. A CIR Expert , on reviewing toxicity data, has concluded that it is safe to use as a cosmetic ingredient up to levels of 1% for applications in cosmetic products. It enhances the penetration of some compounds as it chelates calcium, and thus disrupts intercellular bridging. This should be taken into when formulating ingredients designated as safe primarily because they are not significantly absorbed. Concerns over inhaled formulations were alleviated as the maximum dose was below that which produced reproductive or developmental toxicity. (Final Report (12) 1999). It is a significant eye and skin irritant. Tetrasodium EDTA is FDA approved for injectables, inhalants, ophthalmics, orals and topicals. The data the level and use in this product. Allantoin
RM: 0393
This heterocycluc organic compound occurs widely in the animal and vegetable kingdom as the active principle of comfrey root and the metabolic end-product in lower animals and has been used for many years in the medical field for treatment of skin disorders. More recently it has been used in the cosmetic field, due to its keratolytic properties, in a wide variety of creams and lotions, at levels of 0.1 - 0.5%. It is FDA approved as a Category I (safe and effective) skin protectant. The non-toxic, non-irritant, non-allergenic, non-sensitizing nature of Allantoin, together with the fact that no adverse effects have been reported in its topical use, justify the use and level of it in this product. PEG-40 Hydrogenated Castor Oil
Cremophor RH40
RM 0419
This polyethylene glycol derivative of hydrogenated castor oil is used as an emulsifying or solubilising agent in a wide variety of cosmetic products, typically at concentrations up to 5%. It is also used in a range of pharmaceutical forms and in food- applications. A CTFA Cosmetic Ingredient Review Expert has reviewed the toxicity of PEG-40 Hydrogenated Castor Oil and considered it safe for use in this and all other cosmetic products at a concentration of 100% (IJT 16(S1), 269 - 306, 1997). Dimethicone propyl PG-betaine
30% Abil 9950
RM 0713
A surfactant and conditioner in hair and skin products dimethicone propyl PG-betaine is used at concentrations 0.5 - 5%. Animal tests show it has low acute toxicity, very slight skin irritancy and its non-irritancy to eyes, combined with the manufacturers statement that no adverse effects have been observed or reported justify its use and level in the this product.
Benzyl Alcohol
20%
Euxyl K100
RM 0714
Benzyl Alcohol is an aromatic alcohol used as a preservative, solvent and perfumery component in cosmetics. A CTFA Cosmetic Ingredient Review Expert has reviewed the toxicity of Benzyl Alcohol and concluded that it can be safely used in cosmetic formulations up to 5%, and up to 10% in hair dyes; whereas there was insufficient data to its use in products which are inhaled. (IJT 20(S3), 23 - 50, 2001). The Cosmetic Products (Safety) Regulations 2003 limit its use as a preservative to a maximum concentration of 1% in this and all other cosmetic products; when used as a solvent or in perfumes there is no maximum limit. The 7th Amendment 2003/15/EC to Council Directive 76/768/EEC, to be adopted before September 2004 requires the inclusion of Benzyl alcohol (because of its likelihood of causing allergenic reactions) in the list of ingredients when its concentration exceeds 0.001% in leaveon products and 0.01% in rinse-off products. The data the level and use of Benzyl Alcohol in this product.
Methylchloroisothiazolinone Methylisothiazolinone
0.5% Euxyl K100 0.2% Euxyl K100
RM 0714 RM 0714
Methylisothiazolinone and Methylchloroisothiazolinone are heterocyclic organic compounds used in cosmetics as a broad spectrum preservative system. A CTFA Cosmetic Ingredient Review Expert has reviewed the toxicity of Methylisothiazolinone and Methylchloroisothiazolinone and concluded that they may be safely used at a concentration not exceeding 15 ppm in rinse-off products and at a concentration not to exceed 7.5 ppm in leave-on cosmetic products. This safe use refers to a mixture containing 23.3% Methylisothiazolinone and 76.7% Methylchloroisothiazolinone. (JACT 11(1), 75 - 128, 1992). The Cosmetic Products (Safety) Regulations 1996 limit their use as a preservative to a maximum concentration of 0.0015% of a mixture in the ratio 3:1 of Methylchloroisothiazolinone to Methylisothiazolinone in all cosmetic products. The data the level and use of Methylchloroisothiazolinone to Methylisothiazolinone in this product. Cocamidopropyl betaine
Tegobetain F50
RM: 0997
This zwitterionic ammonium compound is used as an amphoteric surfactant and thickener at levels up to 1% for hair, shower and bath preparations and for pharmaceuticals; it is an antiirritant for anionic surfactants. A CTFA Cosmetic Ingredient Review Expert has reviewed the toxicity of Cocamidopropyl Betaine and concluded it is safe for use in rinse-off products; whereas for leave-on products the concentration should not exceed 3%., due to its irritation potential (JACT, 10(1), 1991). Reports of skin sensitization in humans is considered to be due to the presence of unreacted starting materials. The data the level and use in this product. Sodium Laureth Sulfate
28% SLES 28%
RM: 1310
Sodium Laureth Sulfate is an anionic surfactant, widely used in detergents and personal care products. A CTFA Cosmetic Ingredient Review Expert has reviewed the toxicity of Sodium Laureth Sulfate , and concluded that it is safe as presently used in this and other cosmetic products at concentrations exceeding 50%, though recognising that its use may result in eye and skin irritation. (JACT 2 (5) 1 - 34, 1983). Sodium Laureth Sulfate is also approved by the US FDA for topicals and for food applications. The data the level and use in this product.
Coco-glucoside 30% Glyceryl Oleate 30%
Lamesoft PO65
RM: 1454
A lipid layer enhancer for surfactant cleansers, Lamesoft is used as a viscosity builder in shower gels, foam baths, hair shampoos and baby products. It is a severe eye irritant, and a slight irritant to the skin and mucous membranes. The level and use in this product can be judged as safe. Coco-glucoside
30% Lamesoft PO65
RM: 1454
This non-ionic surfactant, the condensation product of coconut alcohol with glucose, with dermatological properties is also used as a foam control agent in cosmetics and as an emulsifier in dermopharmaceuticals. It has no known toxicity, but is a skin and eye irritant. The level and use in this product can be judged as safe. Glyceryl Oleate
30% Lamesoft PO65
RM: 1454
The monoester of glycerin and oleic acid, Glyceryl Oleate is used as an emollient, emulsifier, thickener and opacifier in cosmetics, at concentrations up to 5%. It is FDA approved for oral pharmaceuticals and amongst many other applications is used in food and food- products. A CTFA Cosmetic Ingredient Review Expert has reviewed the toxicity of Glyceryl Oleate and considered it safe to use up to levels of 5% in this and all cosmetic products. (JACT 5(5), 391 - 413, 1986). Animal studies showed no oral toxicity, minimal to severe dermal irritation, and minimal to moderate eye irritation. Formulations containing 5% Glyceryl oleate were non irritating and non-phototoxic in human tests. The level and use in this product can be judged as safe. Hydrolyzed wheat protein/PVP crosspolymer 25% Hydrotriticum PVP 25/75 RM: 1780
This hydrolyzed wheat protein/polyvinylpyrrolidone complex is used as a conditioner and film former for hair and skin products, where its use is recommended at 1-5%. The manufacturers expect it to be non-toxic by oral and dermal routes and a non-irritant to eyes and skins. There is limited toxicological available on the complex but the hydrolysed wheat protein moiety is considered to be non-toxic. A CIR review has reviewed the toxicity of both PVP and a PVP/VA copolymer and considered them to be safe as cosmetic ingredients, at levels of up to 35% for the former and greater than 50% for the copolymer; with animal studies showing them to be non-toxic, non-irritant to eyes and skin and non-skin sensitising, the latter being confirmed also in human studies. (IJT (S4) 95-130, 1998; JACT 2(5) 141-159, 1983). The data justify the level and use in this product. Aqua 49% Sea Care Propylene glycol 49% Chondrus Crispus (Carrageenan) extract 1%
RM1817
The hydroglycolic extract of red seaweed, Chondrus Crispus (Carrageenan), is used as a moisturiser and conditioner at a recommended level of 3% in hair and skin care products. Non- irritant to the eyes and skin, there is very limited toxicological data available, with much of the toxicological studies on seaweeds concentrating on the suspected potential of phycocyanin found in blue-green algae of being allergenic and of causing dermatitis. The limited data and very low level of use in this product justifies its safe use.
Chondrus Crispus (Carrageenan) extract
0.5% Sea Care
RM1817
The red algae Chondrus Crispus (Carrageenan) is used as an emollient in cosmetics and as a thickening agent, binder and gellant in food, cosmetics and pharmaceuticals at 1-5%. It is FDA approved for use in orals and topicals; and is approved for use in Japan. Concerns about the posssible promotion of colon cancer have been alleviated by a t FAO/WHO Committee who after reviewing all the toxicology and carcinogenic studies on Carrageenan has classified Carrageenan as a food additive ADI (acceptable daily intake) "not specified", the most favourable ADI for a food additive. The data justify the level and use in this product.
Propylene glycol
49% Sea Care
RM1817
An aliphatic dihydric alcohol, propylene glycol is used as an extractant, solvent, conditioning agent and humectant in thousands of cosmetic formulations. A CTFA Cosmetic Ingredient Review Expert has reviewed the toxicity of Propylene Glycol and considered it safe to use up to levels of 50% in this and other cosmetic products (JACT 6 (1); 23-51, 1987). The imposition of an upper limit was considered necessary because of the potential for skin irritancy and sensitization. It is also used in food applications and as a solvent in pharmaceutical preparations. In the US it is FDA approved for orals, parenterals, topicals and it is approved with limitations in Japan. Amodimethicone 20% C11-15 Pareth-7 Laureth-9 Glycerin Trideceth-12
30% Silicone SME 253
RM: 2119
This microemulsion of aminopropylaminoethyl polysiloxane, containing C11-15 pareth-7, laureth-9, glycerin and trideceth-12, is used in rinse-off conditioners. The manufacturer states that all components comply with regulations related to personal care products in the US, EU Canada, Japan, Korea and China. It is a skin irritant and may cause serious damage to eyes. Aerosols have a high potential for inhalation toxicity, and exposure must be avoided when spraying alone or in mixtures.
Amodimethicone
20% Silicone SME 253
RM: 2119
The silicone polymer end-blocked with amino functional groups is used as a hair conditioning agent at concentrations up to 15%. A CTFA Cosmetic Ingredient Review Expert has reviewed the toxicity of Amodimethicone and considered it to be safe as a cosmetic ingredient at a maximum concentration of up to 3% (CIR Final Report 2/00). The considered that it would not be significantly absorbed into the skin because of its large molecular weight. Concerns over inhalation were alleviated as manufacturing processes for cosmetic formulations produce particle size distributions that are not significantly respirable. The data justify the use and level in this product. C11-15 Pareth-7
Silicone SME 253
RM: 2119
A linear alkyl ethoxylate C11-15 Pareth-7 is used as a non-ionic surfactant and emulsifier in cosmetics and in the manufacture of food articles. The data the low level and use in this product.
Glycerin
Silicone SME 253
RM: 2119
The polyhydric alcohol, glycerin, has a long history of use as an emollient and conditioning agent in cosmetic products at maximum levels of 50%. It is also used as an active ingredient in external and internal drug products and is a permitted food additive. It is FDA approved for ophthalmics, orals, parenterals, dentifrices, imtermuscular injectables and rectals. Glycerol is safe for us in this product.
Laureth-9
Silicone SME 253
RM: 2119
The PEG ether of lauryl alcohol, Laureth-9 is a non-ionic emulsifier which is also used in food and packing materials, as a spermicide and in the treatment of vein disorders. It has a low order of toxicity and is non-volatile. The data and its low level justify its use in this product. Trideceth-12
Silicone SME 253
RM: 2119
The PEG ether of tridecyl alcohol, Trideceth-12 is a non-ionic emulsifier and surfactant in cosmetics, which is also used as a defoamer in food and packing materials. There is limted toxicological data available but its very low level justifies its use in this product. Parfume Fragrance Vibrant Days 157108
Fragrance Oils
RM2213
The perfume complies with IFRA guidelines, and a safety evaluation has been undertaken. 4. Assessment of safety for human health and the finished product. The shampoo is based on conventional cosmetic ingredients for this type of product. Similar formulations have been marketed for many years without significant adverse effects. This shampoo is not considered to represent any undue hazards with respect to human health in normal use and under reasonably foreseeable misuse
Prepared By:……………
Date:……………
MATERIAL SAFETY DATA SHEET 1 IDENTIFICATION OF SUBSTANCE/PREPARATION AND COMPANY PRODUCT: ANDREW JOSE JLIFE CATCH A WAVE CURL DEFINING SHAMPOO PRODUCT CODE: UM0362 Company Identification:
Universal Products Manufacturing Ltd. Fairfield Bradshaw Lane Greenhalgh Kirkham Preston Lancashire PR4 3JA
Emergency Telephone:
01772 685777 (Mon - Fri 8.00 - 6.00) Technical Director 01772 725186 - all other times
2. COMPOSITION/INFORMATION AND INGREDIENTS
Hazardous Ingredients: Substance Sodium laureth sulfate Cocamidopropyl betaine
Concn 9.8 wt% 4.32 wt%
Hazard Xi Xi
R phrases R36/38 R36
3. HAZARDS IDENTIFICATION Health Hazards:
Non-hazardous..
4. FIRST AID MEASURES Ingestion: Rinse mouth with water. Give milk or water to drink. Obtain medical advice. Inhalation:
Not applicable.
Skin : Not applicable Eye :
Immediately rinse eyes with plenty of water. Remove any lenses. If tissue damage or persistent irritation is apparent, obtain medical advice immediately.
5. FIRE FIGHTING MEASURES Extinguishing Media:
C02, dry chemical, chemical foam, water spray or mist (not water jet).
Special Exposure Hazards: Special Protective Equipmen:
Halogen and nitrogen decomposition products expected. Self-contained breathing apparatus or supplied-air breathing apparatus may be required.
6. ACCIDENTAL RELEASE MEASURES Personal Precautions: Not applicable. Environmental Precautions: No specific precautions advised. Methods of Cleaning: Absorb the material onto porous, inert material, such as sand, earth etc and dispose of in accordance with local regulations. 7. HANDLING AND STORAGE Storage Conditions:
Store indoors at constant temperature, preferably around 150C. Keep away from oxidising agents.
General Handling Precautions: Handle in accordance with good occupational hygiene and safety practices. Avoid with skin and eyes. Do not ingest undiluted material. 8. EXPOSURE CONTROLS/PERSONAL PROTECTION Exposure Controls: Personal Protection:
Not applicable If excessive exposure is anticipated the following protection measures should be taken: Hand protection: Disposable/rubber gloves. Skin protection: Overalls with protection to arms.
9. PHYSICAL AND CHEMICAL PROPERTIES Appearance: Odour pH: Boiling Point: Melting Point: Flash Point: Flammability (Solid Gas): Explosive Properties: Oxidising Properties: Wt/ml @ 200C: Solubility: Partition Coefficient Refractive Index
A clear, pale straw, viscous liquid. Characteristic. 5.00 - 6.00 at 25ºC N/A. N/A. >100°C. N/A. Non-explosive. Non-oxidiser. Not determined. Water dispersible. Not determined. Not determined.
10. STABILITY AND REACTIVITY Stability:
Stable under normal conditions.
Materials to Avoid:
Strong oxidising materials.
11. TOXICOLOGICAL INFORMATION Not hazardous.
12. ECOLOGICAL INFORMATION None available. 13. DISPOSAL CONSIDERATIONS Disposal should be according to local authority regulations. Not a special waste. 14. TRANSPORT INFORMATION UN Number: Not classified under UN Transport Regulations. 15. REGULATORY INFORMATION Non-hazardous.
16. OTHER INFORMATION Nil
Date of Issue…26 February 2004 Issue No:…1…. This Safety Data Sheet has been prepared in order to assist s to perform their own assessment of the requirements for safe handling under the Control of Substances Hazardous to Health Regulations and similar legislation. The information provided in this MSDS is correct to the best of our knowledge, information and belief at the date of its publication, and is, in our opinion consistent with the state of general scientific and technical knowledge at that date, but we cannot accept liability for loss, injury or damage which may result from its use. We must point out that it is the responsibility of any intermediate supplier to ensure that the information contained in this MSDS is ed to the ultimate . If any such ultimate wishes to make arrangements for versions to be sent directly to him, we shall if so notified, be glad to make the necessary entry in our records.
STABILITY TESTING SUMMARY
PRODUCT: ANDREW JOSE JLIFE CATCH A WAVE CURL DEFINING SHAMPOO PRODUCT CODE: UM0362
PACKAGING: 150 ml glass wide neck jar. TEMPERATURES: 5° C, 25° C, 35° C and 45° C. INTERVALS: 1week, 1month, 3, 6, 12, and 24 months.
TESTS PERFORMED
SPECIFICATION
TEST METHOD
CONCLUSIONS: Product fulfils all required criteria, up to and including 24 months.
Prepared By:_______________________________
Approved By:_______________________________
DATE:
RESULT
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