RAPAN Blue Clay Safety Assessment

Safety Assessment

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RAPAN ® Blue Clay
Safety Assessment

Innovant RESEARCH Product Name: Rapan Blue Clay
Formula: RP01
The following Safety Assessment is carried out according to the Council Directive 76/768/EEC, on the Safety of Cosmetic Products and as amended by Commission Directives 2003/15/EC (7th Amendment), 2003/83/EC (30th Amendment), and 2003/80/EC (31st Amendment)

The Assessment is conducted in accordance with the principles of Good Laboratory Practice referred to in Article 1 of Council Directive 2004/ 10/EC on the applications of the principles of good laboratory practice and the verification of their application for tests on chemical substances.

This assessment takes account of:
a) the general toxicological profile of each ingredient used:
b) the chemical structure of each ingredient:
c) the level of exposure of each ingredient;
d) the specific exposure characteristics of the areas on which the cosmetic product will be applied;
e) the specific exposure characteristics of the class of individuals for whom the cosmetic product is intended.

Review of Ingredients.
All of the ingredients have a history of use in cosmetic and toiletry products. Ingredients that are:
o Prohibited under the Cosmetics Directive
o Restricted when used beyond the allowed authorised conditions
o With toxicological data incompatible with the intended concentration and use
o Which have insufficient toxicological data nor safety in use experience
o Which are not properly characterised with regard to purity and analytical composition.
Are excluded.

Related:

Rapan® Blue and Yellow Cambrian Clays

Material Safety Data Sheet of Rapan® Clays

Safety Assessment for RAPAN BlueClay /YellowClay

Rapan Clay Applications

Slimmer Body and Better Skin with Rapan

Detox with Rapan



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		ASSESSMENT Assessment is based on ingredient safety review and information on the final formulation. Ingredient Safety Review Ingredients are listed below. Detailed information on the safety and toxicology of ingredients is held on file by Innovant Research Ltd. Colloidal clay (Blue Clay) Aqua Maris sal (sodium chloride) The above ingredients have been reviewed for potential to be skin irritants, sensitisers or photo-sensitisers In addition in some instances data is available for systemic and sub-chronic toxicity. A review of the literature and of the structural chemistry has been made for each ingredient to estimate the likely potential for genotoxicity, reproductive effects and carcinogenicity. Taking the above into account and taking the safety data on file, it is considered that this formulation is safe for marketing. FINISHED PRODUCT SAFETY This formula is based on known ingredients with history of safe use in cosmetic products. In particular the Assessment has reviewed the safety of the mineral constituents of the product and the levels of traces of heavy metals and also the levels of natural background radioactivity. It is considered that the levels of heavy metals and of natural background radioactivity are well within safe and acceptable levels. It is also considered that the natural minerals are safe to the skin and total body. SUMMARY In reviewing the safety and toxicity profile of the ingredients used and their history of safe use, it is concluded that there are no likely safety hazards from normal use of this product and when used as directed or from foreseeable conditions of misuse The product Rapan Blue Clay is considered safe for sale in all EU countries Dated: April 11th 2006 Dr. JOHN HOPKINS BSc. PhD. MI Biol. C Biol. Safety Assessor Innovant RESEARCH, Newbury, United Kingdom Contacts for order placement SIBERIAN TECHNOLOGIES V.A.S, P.O. Box 338, 630100, Novosibirsk, Russia, info@rapansalt.ru +7 383 2216195 +7 383 2631547 Packaging: 1kg, 5kg Order e-mail: info@rapansalt.ru Order - form +7 3832 2216195 +7 3832 2631547 We include the following in-line documentation: invoice, certificate for Rapan®Clay, Safety Assessment For detailed information on Payment, Shipping costs, Delivery of RAPAN by e-mail: info@rapansalt.ru



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