TO Whom It May Concern. RE: Directors of M/s Actual/Legal Manufacturer & complete address

Transcription

1 ON THE LETTER HEAD OF MANUFACTURER. TO Whom It May Concern RE: Directors of M/s Actual/Legal Manufacturer & complete address I confirm that the Main Board Directors of (Mention company name ) are: All can be contacted at (Manufacturer Company Name, Address, Tel No, Fax No)

2 ON THE LETTER HEAD OF MANUFACTURER. RE: Manufacturer Company Profile TO Whom It May Concern M/s is a private/ limited company with Registered office at having an annual turnover of approximately USD. A part of this turnover is in Malaysia in supplying DXN brand of products to direct selling distributors. We also market our brands overseas in US, Australia, India, Philippines, Singapore, UAE and other countries (Pls add the country name as per the actual records only) The company is a manufacturer of many types of toiletries, personal care and skin care products as per the following description : M/s Manufacturer name and address is accredited to the (Mention if any quality standard body accreditation is there).

3 ON THE LETTER HEAD OF MANUFACTURER/SUPPLIER. To whom it may concern Certificate of Origin (for both the companies) We here by certify that the DXN products listed below supplied by M/s Manufacturer Name & Address are manufactured within (Country of Manufacturing name e.g Malaysia) under current GMP Guidelines and are in conformance with the regulations of the country of origin according to the directives. The products may be marketed in India. The products conform to the (Mention any standard / Safety regulation or Act under which the cosmetics are manufactured in Malaysia) List of all the Product Names:

4 ON THE LETTER HEAD OF MANUFACTURER/SUPPLIER. To whom it may concern Statement of Absence of BSE risk raw materials We here by declare that the products manufactured by M/s Manufacturer Name listed below do not contain any biological bovine, porcine, ovine, or caprine extracts (brain, encephalon, spinal cord or eye material) that may transmit BSE infectious agents. We certify that they comply with the World Health Organisation requirements and therefore subject to a certificate of free sale. List of all the Product Names

5 ON THE LETTER HEAD OF MANUFACTURER/SUPPLIER. To whom it may concern Certificate of Good Manufacturing Practice (for both the companies) We confirm that all the materials used in the manufacture of M/s Manufacturer Name products listed below undergo stringent Quality Control to ensure that they conform to the required specifications. Quality Control checks are also in place at various stages throughout the manufacturing process to ensure that products have been correctly compounded and packed. We confirm that all products manufactured on behalf of M/s Manufacturer Name have been done so in accordance with the principles of Cosmetic Good Manufacturing Practice. We confirm that the products may be marketed in India and conform to Drug and Cosmetics Act 1940 and Drugs and Cosmetics Rules List of all the Product Names

6 ON THE LETTER HEAD OF MANUFACTURER / SUPPLIER. To whom it may concern (for both the companies) Conformance to Cosmetic Product (Safety) Regulations We confirm that the products listed below conform to the (Any safety regulation, standard or Act in vogue in Malaysia or the respective country of Manufacturing/Origin) List of all the Product Names

7 ON THE LETTER HEAD OF MANUFACTURER/SUPPLIER. To Whom it may concern SHELF LIFE STATEMENT (for both the companies) We here by certify that the XYZ brand of products listed below are supplied by M/s Manufacturer Name, Detailed Address- have a shelf of life of at least 30/36 months according to the stability studies that have taken place. List of all the Product Names

8 ON THE LETTER HEAD OF MANUFACTURER/SUPPLIER. FREE SALES DECLARATION TO WHOM IT MAY CONCERN I, the undersigned, (Person Name), Technical Director, M/s DXN Industries (M) SDN. BHD ( D) hereby declare that the product(s) listed below List of all the Product Names manufactured in our factory located at Complete Address can be freely sold in Country of Origin name We confirm that the same products comply with all the cosmetic laws of the Country of Origin, specifically, the (List down the Act and standards under which manufacturing is done) Technical Head/Director (which ever is applicable)

9 ON THE LETTER HEAD OF TESTING LAB/ RESEARCH CENTRE/ GOVT DEPARTMENT SAFETY ASSESSMENT To be done for each product separately Product: (Product Name) (formulated by M/s Manufacturer name) Formula:.. The following Safety Assessment is carried (Please mention any protocol of Safety Standards in Country of Origin) The Assessment is conducted in accordance with the principles of Good Laboratory Practice referred to in. 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: Prohibited under the Cosmetics Directive Restricted when used beyond the allowed authorised conditions With toxicological data incompatible with the intended concentration and use Which have insufficient toxicological data nor safety in use experience Which are not properly characterized with regard to purity and analytical composition are excluded.

10 ASSESSMENT Assessment is based on ingredient safety review and information on the final formulation, including the intended and reasonably foreseeable use, the raw materials and the finished product, stability and a history and record of any reported undesirable effects linked to the use of the product. DESCRIPTION OF THE PRODUCT (To be mentioned like wise for each product) This is a rinse-off product, for application to any relevant part of the body during pregnancy and after pregnancy as a skin cleanser. DESCRIPTION OF INTENDED AND REASONABLY FORESEEABLE USE The product may reasonably be typically used (mention usage pattern) up to 1-3 times daily as required. QUALITATIVE COMPOSITION OF THE PRODUCT Ingredients are listed below. A summary of the toxicology profile of all ingredients is held on file by (Lab Name). The above ingredients have been reviewed for potential to be skin irritants, sensitisers or photo-sensitisers. Where data is available for systemic and sub-chronic toxicity this has been taken into account. The fragrance (..) is formulated to IFRA Guidelines (or dermal safety and is considered safe in this application. 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. MARGINS OF SAFETY Based on the available toxicological literature, Margins of Safety have been calculated for both topical and systemic effects. It was concluded that all ingredients, when considered both individually and in combination have an adequate Margin of Safety. Taking the above into account and taking the safety data on file, it is considered that this formulation is safe for marketing.

11 GOOD MANUFACTURING PRACTICE The product is to be manufactured to adequate standards of Good Manufacturing Practice and there are to be adequate controls in regards to Microbial quality. FINISHED PRODUCT SAFETY The above formulation is based on known ingredients with history of safe use in cosmetic products: Consideration has been made to ensure that all ingredients are toxicologically safe for use during. This Safety Assessment has taken account of: 1. The Quantitative/Qualitative composition of the product, and including the predicted preservative efficacy to prevent microbial spoilage. 2. The intended and reasonably foreseeable use of the product. 3. Margins of Safety for all ingredients considered both individually and in combination. 4. Standards of good manufacturing practice The product is considered safe for sale in all (destination countries). Dated: