2 PRODUCT COMPOSITION

Transcription

1 10, Portman Road, Reading, Berkshire RG30 1EA UK Tel: Fax: ASSESSMENT OF SAFETY FOR HUMAN HEALTH Client: FAO: Snazaroo Holdings Ltd Unit la-ld & 2D BruneI Way Mart Road Industrial Estate Minehead Somerset TA245BJ Adrian Ryan Sample: SNAZAROO FACE PAThIT Amendment to report S /GC dated 2ir. June 2007 S /AMl/GC Reference No: Order No: 6454 Date received: 04/06/2007 I have reviewed the information supplied by Snazaroo Holdings Ltd, namely the ingredients, their chemical nature and toxicological profile and intended consumer exposure of the finished product. Based on the information received, together with the toxicological profile of the ingredients and an assessment of the final product subject to the provisions indicated within the report being satisfied, the product put on the market should not cause damage to human health when applied to the body under normal and reasonably foreseeable conditions of use. If this product is reported to cause significant adverse reaction amongst consumers (e.g. with an abnormally high number of complaints) the undersigned must be informed and a new evaluation made. Ian Steedman C.Chem, MRSC Technical Consultant - Chemicals 24 th July 2007 All comments relate only to the formulation(s) received for evaluation. This report shall not be reproduced except in fulj without the prior written permission of the testing laboratory.... Page 1 of 8 ~------_._ ,.----.,.---., Registered ill IO.nghnd and Wales Rq;imation No

2 S /AMl/GC 1 LEGISLATION This document addresses the requirements of the ED for an "assessment of safety for human health" of finished cosmetic products (Directive 93/35/EEC, Article 7a, subsection Id) by considering the general toxicological profile of the ingredients and an assessment of the final product. 2 PRODUCT COMPOSITION The sample consisted of fonnulation for the following range of face paints. Cosmic Dark Orange Cosmic Light Green Cosmic Yellow Sparkle Turquoise Sparkle Blue Sparkle White Sparkle Red Sparkle Pink Sparkle Salmon Pink Sparkle Yellow Light Brown Light Beige Burgundy Pale Pink Complexion Pink Grass Green Lime Green Pale Blue Royal Blue Pale Yellow Light Grey Bright Red Cosmic Pink Cosmic Light Red Cosmic Dark Green Electric Green Electric Blue Sparkle Pale Green Copper Silver Gold Electric Black Rust Brown Barely Beige Maroon Orange Teal Dark Green Pale C--reen Sky Blue Dark Blue Bright Yellow Black White Cosmic Dark Red Cosmic Light Orange Sparkle Orange Sparkle Green Electric Purple Sparkle Lilac Sparkle Gun Metal Grey Dark Brown Beige Brown Dark Orange Lilac Purple Fuchsia Pink Peach Turquoise Bright Green Sea Blue Apricot Ochre Yellow - Dark Grey Bright Pink Dark Orange The fonnulation was supplied by Snazaroo Holdings Ltd. The ingredients were translated into European lnci format and listed as follows: Ingredients. Concentration by % Page 2 of8

3 S /AMI/GC May contain: To 100 MicalCI 77891/CI CI45370 CI 45410/CI CI 45370/CI MicalCI CI77510 CI19140 CI77891 CI77491 CI CI45350 CI 19140/CI CI42090 CI77007 CI15850 CI 77491/CI CI 19140/CI CI77499 CI CII7200 CI lngredient REVIEW Each ingredient was reviewed with respect to ingredient quality specification, recorded toxicological data, and the pennitted restricted status in the EC Cosmetics Directive (76/768/EEC). Talc Talc is a filler and adsorbent used as a base in many cosmetic products. It has no specific restrictions within the current European cosmetic legislation for this application and is considered acceptable for this type of product. Propylene Glycol 1, 2-propanediol or propylene glycol is used as a solvent and emollient in numerous cosmetic product applications. An evaluation by the Cosmetic Ingredient Review Expert Panel (JACT 13(6): confirmed 02/04 and HI 25 (S2) 2006) has designated this ingredient safe for use in cosmetic products at concentrations not exceeding 50%. Propylene glycol has no specific restrictions within the current European cosmetic legislation. It is considered acceptable for this application.. PEG-8 Stearate PEG-8 Stearate has had long-term usage in the cosmetic industry as an emulsifying agent and surfactant. An evaluation by the Cosmetic Ingredient Review Expert Panel has designated this ingredient safe for use in cosmetics at concentrations up to 10% It has no specific restrictions within the current European cosmetic legislation. It is considered acceptable in this application.... Page 3 of 8 ~ / Specialised Technology Resources (UK) Ltd.

4 S /AMl/GC Glyceryl Stearate Glyceryl stearate is used in cosmetic products as an emollient and emulsifying agent. A review by the Cosmetic Ingredient Review (CIR) Panel has designated this substance as safe for use in cosmetic products when used at a concentration of up to 50% (JACT 1 (4) 1982). Glyceryl stearate has no specific restrictions within the current European cosmetic legislation and is considered acceptable 'ror this application. Propylene Glycol Ceteth-3 Acetate Propylene glycol ceteth-3 acetate (CAS Number ) is used in cosmetic products as a non-ionic surfactant. Propylene glycol ceteth-3 acetate is not classified as a dangerous substance.in The Dangerous Substances Directive 67/548/EEC. A review of the use of propylene glycol ceteth-3 acetate on the Internet indicates it does have a wide use in cosmetic products. No material safety data sheets were identified indicating irritancy or sensitisation associated with the substance. It was considered that the use of this substance in the formulations at the concentrations indicated was acceptable. Carbowax Polyethylene glycols have had long term use in the cosmetic and pharmaceutical industry as emollients and humectants. They have no specific restrictions within the current European cosmetic legislation. They are considered acceptable for this application. Mica Mica (Cl 77019) is widely used as pearlising agent and opacifier.in cosmetic products. Mica has no specific restrictions within the current European cosmetic legislation and is considered acceptable for use in this application. Aqu' Water has ubiquitous use throughout the food, cosmetic and pharmaceutical industry. It is considered to represent no significant toxicological hazard in this application. PEG-7S Lanolin This ethoxylated lanolin is used in cosmetic products as an emollient, emulsifying agent and surfactant. A review by the Cosmetic Ingredient Review Expert Panel (Ref: JACT 1(4) 1982) designated this ingredient as safe for use in cosmetics at concentrations not exceeding 25%. Studies have shown that trace amounts of 1,4-dioxane, a by-product in ethoxylated ingredients may be present in this raw material. (The determination of 1,4-dioxane in ethoxylated surfactants. 1. Soc. Cosmet. Chem. 31 :329±337.). Dioxane is prohibited in Annex II of the EC Cosmetics Directive (II/343) except for traces that can not be reasonably removed during or after manufacture and provided that the presence of such traces does not cause the product to fail to comply with the general safety requirement in article 2 of the EC Cosmetics Directive. 1,4 dioxane is also classifies as a category 3 carcinogen under the Dangerous Substance Directive. The concentration of 1,4 dioxane must be kept as low as possible. Studies have indicated that a dioxane content of less than 20ppm to be acceptable for this type of ingredient. Separate documentation with respect to the concentration of 1,4 dioxane in this raw material must be available in the product information package for this product. PEG-75 lanolin has no specific restriction within current European cosmetic legislation and with the above caveat is considered acceptable for this application. Page 4 of 8 ~ / Specialised Technology Resources (U I ) LlJ.

5 S /AMl/GC Phenoxyethano) PhenoxyethanoJ is a solvent and preservative used frequently in cosmetic products. It is restricted in the EC Cosmetics Directive (Annex VV1, 29) to a maximum concentration of 1.0%. The concentration stated within the formulation supplied complies with this maximum limit. It is considered acceptable for use in this product at this concentration. Paraben The paraben group of preservatives has had long-term usage in the cosmetic industry. Each paraben ester is restricted, by the EC Cosmetics Directive (Annex VV1, 12), to a maximum concentration of 0.4%, with the total concentration of all parabens not to exceed 0.8%. Studies have shown that the paraben group of preservatives is safe for use at concentrations not exceeding the maximum limit in the EC Cosmetics directive (Ref. CIR Compendium, CrR Review, Feb, 1, 1995). The stated paraben concentration is below the maximum allowable level and therefore is considered acceptable for use in this product. CI77891 Titanium dioxide (CI 77891) is permitted for use as a colourant in all cosmetic applications. Titanium dioxide is also commonly used as filler and has had long-term usage as a food ingredient. The EC Cosmetics Directive (Annex IV/1) requires this ingredient to comply with the food colourant specification E171, as stated in the EC Directive 65/496/EEC concerning the colouring matter in foodstuffs. Compliance with this specification must be evident in the product information package. With this caveat this ingredient is considered acceptable for use in this application. CI77491 Iron oxides are permitted for use in all cosmetic applications. The EC Cosmetics Directive (Annex IV/1) requires the raw material to comply with the E172 specification as stated in the EC Directive 65/469/EEC concerning the colouring matter in foodstuffs. Separate certification relating to the requirements of Directive 65/469/EEC shall be held in the product infonnation file for this product and with this caveat this ingredient is considered acceptable for this application. CI45370 This is a permitted colourant in the EC Cosmetics Directive (Annex IV/1) with the following restrictions: Not more than 1% 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid Not more than 2% 2-(bromo-6-hydroxy-3-oxo-3 -xanthen-9-yl)benzoic acid This information and evidence of compliance must be evident in the raw material specification for the ingredient in the Product Information Package and only with this caveat is this ingredient considered acceptable for this application. CI45410 CI is permitted for use in all cosmetic products within the EC Cosmetics Directive (Annex IV/l) but the raw material must comply with the following specific restrictions: 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid Not to exceed 1% 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid Not to exceed 2%.. ~ / Specialised Technology Resources (UK) Ltd, Page 5 of 8

6 S AM l/gc This information and evidence of compliance must be evident in the raw material specification for the ingredient in the Product Information Package and only with this caveat is this ingredient considered acceptable for this application. CI45380 This is a pennitted colourant in the EC Cosmetics Directive (Annex TV/1) with the following restrictions: Not more than 1% 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid Not more than 2% 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid The insoluble Ba, Sr, and Zr lakes, salts and pigments are also pennitted by the EC Cosmetics Directive. CI45370 This is a permitted colourant in the EC Cosmetics Directive (Annex TV11) with the following restrictions: Not more than 1% 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid Not more than 2% 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid This infonnation and evidence of compliance must be evident in the raw material specification for the ingredient in the Product Infonnation Package and only with this caveat is this ingredient considered acceptable for this application. C Ferric ferrocyanide is permitted for use in all cosmetic products (Annex IV/I). The raw material specification for this ingredient must show it to be free from cyanide ions. This must be evident in the product infonnation package for this product. With this caveat this colourant is considered acceptable for this application. CI FD&C Yellow No.5 (Cl 19140) is permitted for use in all cosmetic products. Annex IV of the EC Cosmetics Directive has the restriction that the colourant must comply with the food colourant specification EI02 (as stated in the EC Council Directive of n rd October 1962 concerning the foodstuffs and colouring matter ~ as amended). Compliance with this specification must be evident in the Product Infonnation Package for this item. With this caveat this colourant is considered acceptable for this application. CI15985 F D&C Yellow No. 6 is a cornmon colourant used in food, cosmetic and pharmaceutical products. It is permitted in all cosmetic applications, however it must comply with the food colourant specification E 11 O. This must be evident in the product infonnation package or dossier for this item. CI45350 D&C Yellow No.8 is a pennitted colourant for use in all cosmetic products as indicated in the ED cosmetic products directive (Annex IV/1). This colourant is restricted to a maximum of 6% in the product. The product infonnation package for this product must include data demonstrating compliance with this requirement. Page 6 of8 ~ / Specialised 'lechnology Resources (lik) Ltd.

7 SNAZAROOFACEPA~ S /AMlIGC CI42090 FD&C Blue No.1 is a permitted colourant in the EC Cosmetics Directive (Annex N /1) with no restrictions and is therefore considered acceptable for this type of product. CI77007 This sulpho-silicate colouring compound (Cl 77007) (Annex lv/1) is permitted for use in all cosmetic products, with no specific restrictions in the current European cosmetic legislation. CI15850 D&C Red No.6 and 7 are permitted for use in all cosmetic products within the EC Cosmetics Directive (Annex IVII) with no specific restrictions and are considered to be acceptable for this application. CI77499 Iron oxides are permitted for use in all cosmetic applications. The EC Cosmetics Directive (Annex IV/1) requires the raw material to comply with the E172 specification as stated in the EC Directive 65/469/EEC concerning the colouring matter in foodstuffs. Separate certification relating to the requirements of this directive must be held in the product infonnation file for this product and with this caveat this ingredient is considered acceptable for this application. CI16035 FD&C Red No. 40 (Annex IV/1) is a permitted colourant for use in all cosmetic applications, with no restrictions and is considered acceptable for this type of product. CI ]7200 D&C Red 33 (Cl 17200) is permitted for use in all cosmetic products with no specific restrictions within the EC Cosmetics Directive (Annex IV/1). It is considered acceptable for this application. CI47005 D & C YeJlow No. 10 (Cl 47005) is pennitted for use in all cosmetic products. The EC Cosmetics Directive (Annex IV/1) has the restriction that the colourant must comply with the food colourant specification E104 (as stated in the EC Council Directive of23 rd October 1962 concerning foodstuffs and colouring matter-as amended). Compliance with this specification must be evident in the product information package. With this caveat this ingredient is considered acceptable for use in this application. 4 ASSESSMENT OF SAFETY FOR HUMAN HEALTH OF THE FINISHED PRODUCT 4.1 Preservative System The preservative system is indicated as phenoxyethanol 0.50%, methylparaben O. I20 %, ethylparaben 0.028%, propylparaben 0.014%, butylparaben 0.028% and isobutylparaben 0.014% supplied as the proprietary preservative blend Phenochem. The total concentration of Phenochem present is 0.7% (7000 ppm). To effectively inhibit micro-organisms commonly encountered in the manufacturing process and in general circulation the minimum inhibitory concentration should be exceeded. The following table indicates the minimum inhibitory concentrations (MlC) for some commonly encountered micro-organisms:... Page 7 of 8 ~ / Specialised Technology Resources (UK) Ltd.

8 SNAZAROOFACEPMNT S AM [/OC Ore:snism MIC Values in PPM Staphylococcus aureus 1,500 Bacillus subtilis 1,500 Lactobacillus 1,250 Pseudomonas aeru~inosa 3,000 E, Coli 1,250 Proteus vul~aris 2,250 Candida albicans 1,000 Asper~illus ni~er 2,000 Data obtamed from 1111 II I III The concentration of the preservative blend should theoretically inhibit the commonly encountered micro-organism. However, microbiological challenge testing would be the definitive way of establishing the preservative efficacy of the preservative system. 4.2 Microbiological Quality The cosmetic industry guidelines state the following maximum limits: Applications intended for use in the vicinity of the eyes Other general cosmetic applications 100 cfulg 1000 cfu/g The following organisms are required to be absent in O.lg of the product: Pseudomonas aeruginosa Staphylococcus aureus Candida albicans Separate certification must be referred to with respect to compliance with this requirement. 5 OVERALL TOXICITY RATIONALE This product is applied undiluted in the form of a thin layer on the face and left on all day, with an application rate of once to twice a day. Based on the normal and reasonably foreseeable usage of this product, it is considered to avail the degree of safety, on a toxicological basis, that would be reasonably expected by the consumer. It must be ensured that all ingredients are of an appropriate quality (i.e. cosmetic grade or higher) with this documentation available for reference in the product information package for this item. 6 SUMMARY This face paint fo lation is based on conventional cosmetic ingredients for this type of product. Similar formulations have been marketed without known significant adverse effects. This product is not considered to represent any undue hazards with respect to human health in normal use and under reasonably foreseeable use. ***** Page 8 of8 K) Ltd.