TANZANIA FOOD AND DRUGS AUTHORITY

Doc. No.: TFDA/DMC/CCM/G/001TANZANIA FOOD AND DRUGS AUTHORITYGUIDELINES ON SUBMISSION OF DOCUMENTATION FORMARKETING AUTHORIZATION OF COSMETIC PRODUCTSMade under the Tanzania Food, Drugs and Cosmetics (Control of Cosmetics )Regulations, 2010Third EditionSeptember, 2017P. O. Box 77150, EPI Mabibo, Off Mandela Road, Dar es Salaam, Tel: 255-222450512/2450751/ 2452108, Fax: 255-22-2450793, Website: www.tfda.or.tz, Email:info@tfda.or.tz1

Table of contentsTABLE OF CONTENTS .2ACKNOWLEDGEMENTS .4ABBREVIATIONS .5INTRODUCTION .7GLOSSARY OF TERMS .8SECTION 1: GENERAL REQUIREMENTS .111.1Language .111.2Classification of cosmetic products .111.3Marketing authorization .121.4Who should apply? .121.5Applicant .121.6Responsibility of Applicant .121.7Classification of applications .131.8How to submit an application .141.9Requirements for submission .141.10Application format .151.11Confidentiality .151.12Composition of a Cosmetic product .151.13Payment of fees .161.14Reporting of adverse reactions .161.15Record keeping .16SECTION 2: PROCESSING APPLICATIONS FOR REGISTRATION .172

2.1Receiving of applications .172.2Processing of applications.172.3Application for review of refusal of registration .182.4Validity of registration .182.5Termination of registration .18SECTION 3: PACKAGING AND LABELING OF COSMETICS .203.1Packaging requirements .203.2Labeling requirements .20SECTION 3: ANNEXES .23Annex I: Application format for registration of cosmetic product .23Annex II: Application format for variation of registered cosmetic product .26Annex III: Application format for renewal of registration of cosmetic product .28Annex IV: FORMS OF COSMETICS .31Annex V: INTENDED USES.333

AcknowledgementsThis is the third edition of the Guidelines for Submission of Documentation forMarketing Authorization of Cosmetic Products in Tanzania Mainland. It supersedesthe second print out which was in use since February, 2015.I would like to thank all who worked tirelessly to draft the first and second editions ofthe Guidelines which form the basis for this edition. Acknowledgements areparticularly extended to Ms Grace Shimwela (TFDA), Ms Gudula Mpanda (TFDA), MsJeniva Jasson (TFDA), Mr Jackson Kiberenge (TFDA), Ms Rosemary Aaron (TFDA), MsMarcia Awe (TFDA), Dr Itikija Mwanga (TFDA), Mr Gerald Magola (TBS) and Dr JoshuaKajura (Amana Hospital) for incorporating new ideas in this edition and making itmore useful to applicants.Special thanks are also extended to TFDA esteemed stakeholders and dealers incosmetics for their commendable inputs during development of this edition and theChemical Inspection and Regulation Services of China, Department of Health Bureauof Food and Drugs (BFAD) of Philippines, Drug Administration and Control Authority(DACA) of Ethiopia and Cosmetic Technical Working Group (CTWG) of Malaysia whosedocuments saved as important references.Last but not the least TFDA Human Medicines Technical Committee is acknowledgedfor constructive comments and inputs during deliberation and final completion ofthese guidelines.Adam Mitangu FimboDirector, Medicines and Complementary ProductsTanzania Food and Drugs Authority4

AbbreviationsFIFOFirst in First OutFSCFree Sales CertificateGMPGood Manufacturing PracticeICIDInternational Cosmetic Ingredient DictionaryINCIInternational Nomenclature of Cosmetic Ingredient nameTFDATanzania Food and Drugs AuthorityTBSTanzania Bureau of StandardsUVUltra VioletTZSTanzanian Standards5

ForewordThe guidelines have been developed to assist applicants who wish to place theircosmetic products in Tanzanian market to provide the required information formarketing authorization. First edition of these guidelines was developed in the year2009 which was subsequently reviewed into second edition in the year 2015. Sincethen advanced marketing and development in cosmetic industry has been extensivelyerupted which led on the need to develop simplified process for marketingauthorization of cosmetics to keep pace with the market advancement andstakeholders satisfaction. This third edition has been developed to address thosechallenges and various concerns from the stakeholders related to cosmetics marketingauthorization.These guidelines have classified cosmetic products into two groups to facilitatemarketing authorization process and their regulations as a whole. Marketingauthorization process particularly for non special cosmetics has been simplified toimprove their access and use. The guidelines have also adopted EU directives on therequirements for composition of a cosmetic product in particular to the list ofprohibited ingredients and substances that are permitted to a certain level in order toensure safe and quality products on the market.The new guidelines require submission and processing of applications for marketingauthorization direct through the online system which will not only shorten approvalprocess but also ensure submission of reliable information from the applicants.Applicants are therefore encouraged to familiarize with these guidelines and followthem. However the requirements stipulated in these guidelines are minimal andwhenever there will be additional information regarding products they should besubmitted to the Authority.Adherence to these guidelines will ensure that relevant information are provided formarketing authorization of cosmetics. This will facilitate efficient and effectiveevaluation and approval processes of the applications. It will also help to avoid querieswhich results in unnecessary delays of the approval process.It is anticipated that the guidelines will be revised regularly in response to theknowledge and experiences gathered from time to time. We therefore welcomecomments and inputs that will help in improving the guidelines.Hiiti B. SilloDirector GeneralTanzania Food and Drugs Authority6

IntroductionRegulations of cosmetics encompass marketing authorization or registration, premisesregistration, import and export control, inspection and market surveillance. Marketingauthorization is official approval of the cosmetic product to be marketed or distributedin Tanzanian market after assessment of product‟s scientific and manufacturinginformation to ensure their safety, quality and performance to users.All cosmetic products to be manufactured, supplied, distributed or sold in Tanzanianmarket should prior be registered by the Authority. This is in accordance withprovisions of the Tanzania Food, Drugs and Cosmetics Act, Cap 219 and Regulationsmade there under. The Act further requires person who manufacture, supply,distribute or sell cosmetic products to have their premises registered and licensed tocarry out the intended activities.These guidelines are intended to assist applicants who wish to register their cosmeticproducts in Tanzania in providing required information thereby facilitating evaluationand subsequently approval. It describes procedures for submission of documentationfor registration of new cosmetic products, variation to registered cosmetic productsand renewal of registration.The guidelines are divided in three sections. Section one describes the generalrequirements, section two processing applications for marketing authorization whilesection three describe the minimum requirements for cosmetics packaging andlabeling.Assessment of documents submitted for marketing authorization will be based onthese guidelines. Applicants are therefore requested to read the guidelines togetherwith the Tanzania Food, Drugs and Cosmetics Act, Cap 219 and CosmeticsRegulations made there under.7

Glossary of TermsThe terms listed below are defined specifically for the purpose of these guidelines:„„Act‟‟ means the Tanzania Food, Drugs and Cosmetics Act, Cap 219;“Applicant” means a person who submits an application for marketing authorizationof a cosmetic, an update or amendment to an existing marketing authorization to theAuthority who may be a manufacturer or a person to whose order and specifications,the product is manufactured. After the product is registered the applicant shall be“marketing authorization holder”;„„Authority‟‟ means The Tanzania Food and Drugs Authority, or the acronym „TFDA‟established by Section 4 of the Act;“Botanical” means an ingredient that is directly derived from plant and that has notbeen chemically modified before it is used in the preparation of a cosmetic;“Claim” means any message or representation including pictorial, graphic, symbolic orany form of representation, which states, suggests or implies that a cosmetic hasparticular characteristics relating to its origin, function, nature, composition or anyother characteristics;“Colour” means a substance used as an ingredient of cosmetic product solely to givetonality to the product;„„Composition of a cosmetic‟‟ means the ingredients contained in a cosmetic productand their proportions;„„Container‟‟ means a bottle, jar, box, packet, sachet or other receptacle whichcontains or is to contain a cosmetic;„„Cosmetic‟‟ means any article intended to be used by means of rubbing, pouring,steaming, sprinkling, spraying on or otherwise applied to the human body or any partthereof for cleansing, beautifying, promoting attractiveness or altering the appearanceand includes any article intended for use as component of a cosmetic, such articleexclude articles intended beside the above purposes for use in the diagnosis,treatment or prevention of diseases and those intended to affect the structure or anyfunction of the body;“Decorative cosmetics” means a cosmetic intended to modify the appearance of thearea to which they are applied by the use of colour;8

“Flavour” means a substance used as an ingredient of cosmetic product solely toimpart taste to the product;“Fragrance” means a substance used as an ingredient of cosmetic solely to impartodour to the product;“Free Sales Certificate” means a document that indicates that the product is freelysold in that country;“Immediate packaging” means the container or other form of packaging immediatelyin contact with the cosmetic product;“Ingredient of a cosmetic” means any substance which is a component of a cosmeticand includes colouring agents, botanicals, fragrance and flavour;“International Cosmetic Ingredient Dictionary (ICID)” means the latest edition of abook that gives names of cosmetic ingredients published by the American CosmeticsToiletries and Fragrance Association;“International Nomenclature of Cosmetic Ingredient (INCI) name” means a nameused for listing an ingredient on a cosmetic product label;“Labeling” means information written or printed or graphic matter on the immediateor outer packaging and any form of leaflets;“Label of a cosmetic” means any tag, brand, mark, pictorial or other descriptivematter, written, printed, stenciled, marked, embossed or impressed on or attached to acontainer of any cosmetic;“Leaflet of a cosmetic” means and includes any written information related to acosmetic;“Manufacture of cosmetic” means and includes all operations involved in theproduction, processing, compounding, formulating, filling, refining, transforming,packing, packaging, repackaging and labeling of the cosmetics;“Manufacturer” means a registrant (market authorization holder) engaged in themanufacture of cosmetics;“Marketing authorization” means an official approval of the cosmetic product to bemarketed or distributed in Tanzania mainland;9