1 Associação dos Distribuidores e Importadores de Perfumes, Cosméticos e Similares Rua Tabapuã, 649 – Cj 74 – São Paulo – SP - CEP 04533-012 - Brasil Tel/Fax: (+55) 11-3168-4518 adipec@adipec.com.br http://www.adipec.com.br HOW TO REGISTER PERFUMS, COSMETICS AND TOILLETRIES IN BRAZIL By Sergio H.Nascimento Regulatory Affairs Coordinator of ADIPEC (Revised by ASSEVISA & ATVS) 1. Brazilian Regulatory Legislation According to the Brazilian Law # 6.360 promulgated in 23 September 1976, perfumes, cosmetics, toilletries and similar products must be registered at the Brazilian Sanitary Vigilance Agency (ANVISA) a federal organization that belongs to the Ministry of Health and that regulates the manufacturing, importation and sales of cosmetics, perfumes, toiletries, medicine drugs, home care products, medical devices, foods, etc. This particular Law and their updated Directives has established the criteria for product composition (allowed and restricted ingredients), labeling instructions, product registration dossiers, etc. It is important to notice that since 2000, the Law # 6.360 has been regulated through Directives issued by ANVISA establishing rules and procedures very similar to the Cosmetic and Toiletries Directives of the EEC. Such Directives has been discussed and approved in The Mercosul (Latin America Common Market) and adopted in Brazil. As per the Directive # 343/05 issued in December 13th, 2005 cosmetics and toiletries were classified by their in use risk degree and the definition of perfumes, cosmetics and toiletries were changed to: preparations whose ingredients (natural or synthetic) to be used externally in various parts of the human body such as skin, hair, nails, lips, genitals, teeth, membranes of the oral cavity, with the only objective to clean the, odorize them, change their appearance, or correct body odors, or protect and/or keep the body in good conditions. 2. Products Risk Degree 1 (or category 1) Product classified as risk degree 1 (or Category 1) are products whose chemical formulations match the definition of cosmetics, perfumes and toiletries listed above (Directive # 343) and whose properties and characteristics does not required detailed data regarding their in use instructions and use restrictions due to product simple characteristics and composition. Examples: Simple shampoos and conditioners, shaving foams and lotions, make up products, mild creams, products with non anti-aging or non anti-dandruff claims, body lotions and creams without vitamins and UV filters in their chemical formula, etc. Products classified as Category 1 are not registered in ANVISA. They are notified through a dossier containing simple and basic product data and labeling text which is 2 submitted on line without any tax. In general, after the Notification dossier submission, product can be imported and distributed immediately in the market. However, if for any reason ANVISA finds some contradictory data in the Notification dossier, the distributor are asked to clarify the previous data submitted and the notification can, eventually be rejected. ANVISA uses to monitor the Notification process submitted electronically through internet and, in case of any error is found the Notification process can be rejected There is not any previous process analysis, but a detailed an electronic monitoring of the process by the Cosmetic Department of ANVISA . It is important to notice that products classified as Risk Degree 1 cannot present solar filters chemicals in its composition unless in a very small quantity for formulation protection. The importing company must monitor the directives issued by the Brazilian Cosmetics Technical Chamber - CATEC (available in the ANVISA web site) regarding the inclusion of some ingredients that change the Risk Degree classification of the products (Examples, Vitamin C, Vitamin A, camphor, methyl salicilate, etc.). 3. Products Risk Degree 2 (or category 2) Products classified as higher risk degree (or Category 2) are products whose chemical formulation complies with the definition adopted in the ANVISA Directive # 343/2005 but have specific and particular indications (Example: products with “anti” claims, creams with sunscreen filters, creams to be used in the eyes area, hair coloring products, hair straightener products, baby products, etc. ) whose characteristics demands detailed data (in use test reports) regarding their safety and/or efficacy (claims proof) as well as, more detailed data regarding their in use instructions and use restrictions. Products classified as Category 2 must be registered in ANVISA and registration timing is about 60 – 90 days after submission of the registration dossier, if the importing company is not asked to submit any additional data. Along with the submission of the product registration dossier, the importing company must pay a registration tax which value depends on its economical size. In order to import and distribute products that need to be registered, the importing company must wait until the registration number is published at the Brazilian Official Gazette. This is not a requirement for products of Risk Degree 1. 4. Positive and Restrictive Ingredients Listing According to the Brazilian regulations for perfumes, cosmetics and toiletries there are Positive and Restrictive ingredients listings (chemicals which cannot be used in the product formulation, except in the conditions and restrictions established in the current sanitary regulations), listing of UV filters allowed to be included in the formulation without cause any side effect to the consumer skin, and Negative listings (chemicals prohibited to be used in perfumes, cosmetics and toiletries according to the current legislation. Those listings are available in the ANVISA web site. 5. Notification / Registration Valid Date According to the Brazilian Regulatory Legislation for perfumes, cosmetics and toiletries Notification and Registration processes are valid for 5 (five years) and after this period of time, must be renewed 6 months before their expiration date through a similar process since product formulation has not been changed. For products Risk Degree 1, the Notification renewal process will be done without any fee payment. For products Risk Degree 2 it is demanded a new registration process with the payment of a new registration fee. In case of a notification and registration process is not renewed after 5 years, they are automatically canceled by ANVISA system. 3 6. Product Dossier According to the Directive # 343/2005 article 13, the local manufacturer and/or the local importer must have all the product data proving the quality, safety and efficacy of the product manufactured and/or imported. As well as the labeling text and claims must be supported by technical literature or by the test reports done with the product (in the country of origin or locally). All that documents constitute the “Product Dossier”, a collection of product technical documents which must be presented during the ANVISA annual inspection in order to renew the working license of the importing company. This inspection is performed yearly or can be done at any time and is performed by the local health authorities who check all the product documents including the test reports, which eventually were not submitted to the ANVISA during the notification / registration process. In general, the documents to be submitted to ANVISA during the Notification and/or Registration process are copies of the documents of the “Product Dossier”. DOCUMENTS TO PREPARE THE PRODUCT NOTIFICATION/REGISTRATION DOSSIER IN BRAZIL According to the new Brazilian regulations (RDC 211/2005) issued on July 14th, 2005 all the documents listed below will are mandatory for product registration and warehouse inspection. DOCUMENT PRODUCT DOSSIER (AT THE COMPANY) 1) Product composition Sheet (Must be stamped at the Brazilian Embassy or Consulate of the country of origin) Yes 2) Function of each Yes ingredient of the composition sheet 3) Ingredients bibliography or technical references (Only when required) Yes PRODUCT OBSERVATIONS NOTIFICATION AND/OR REGISTRATION DOSSIER Yes (For products 1. Ingredients must be listed category 1 and 2) according to INCI nomenclature. 2. Botanical ingredients must be listed according to the INCI nomenclature or in the Binomial Linné System (in general required for botanical extracts from Asia countries). 3. Dyes must be declared according to the Color Index (CI). 4. All ingredients listed in centesimal composition (%) Yes (For products 1. Each ingredient must be category 1 and 2) identified according to its function (Examples: dye, surfactant, humidifier, emollient, solvent, etc.) Yes (For products category 1 and 2) 1.In general, for all ingredients. For proprietary ingredients and non conventional botanical extracts not listed in the INCI listing. In this case, ANVISA 4 will demand an international bibliography or a technical reference published in Chemical Encyclopedias or any other reputable technical publication. 2. In cases of new cosmetic ingredients an in use safety test report can be demanded by the health authorities. 3. In some cases an ingredient monograph can be demanded by the ANVISA authorities, when the particular chemical does not figure in the INCI nomenclature. 4) Raw material Yes (for products technical specs category 1 and 2) (organoleptics and physical chemistry) No 5) Raw material Microbiological specs 6) Physical Chemical and Organoleptics Specs of the finished product Yes (for products category 1 and 2) No Yes (for products category 1 and 2) Yes (for products category 1 and 2) 1. For each raw material used in the formulation, a summary of its main physical chemical properties is now being demanded (Example: pH, density, molecular weight, viscosity, odor, color, etc.). No need to submit Material Safety Data Sheet (MSDS)! 2. No need to declare the commercial names of the manufacturers of raw materials, when listed in the INCI nomenclature. 3. Regarding of raw materials of animal origin susceptible to transmit BSE the cosmetic product manufacturer must submit to the ANVISA a document certifying that particular raw material is allowed to be used in their country of origin. These documents must be stamped at the Brazilian consulate or embassy, in the country of origin. 1. When applicable 1. A summary of the main physical chemical specifications (pH, density, molecular weight, viscosity, odor, color, etc) and organoleptics (odor, appearance, etc) of the finished 5 7) Finished products Microbiological specs Yes (for products category 1 and 2) Yes (for products category 1 and 2) 8) Manufacturing process Yes (for products category 1 and 2) No 9) Packaging specs Yes (for products category 1 and 2) Yes (for products category 1 and 2) 10) Product stability test results Yes (for products category 1 and 2) (Complete) Yes (for products category 1 and 2) (Summary) 11) Lot Code Yes (for products category 1 and 2) Yes (for products category 1 and 2) No 13) Product claims Proof Test Results (Efficacy product test report) Yes (for products category 2) Yes (only for category 2 products, to proof their specific labeling claims, such as antiwrinkle, antidandruff, antiaging, etc.) 14) Product in use safety test data Yes (for products category 1 and 2) Yes (only for products category 2) 12) Label artwork (Original and in Portuguese language) Yes (for products category 1 and 2) product must be submitted to the health authorities 1. When applicable, a summary of the microbiological test results of the finished product, must be submitted to the Health authorities 1. A simple description of the manufacturing process. Only a general description of the main steps of the production process (simple flow sheet diagram or production block diagram). No need to include process conditions such as temperature, pressure, etc. 1. General description of the primary and secondary packaging including sizing, shape and materials. 1. A summary of the laboratory product stability test results as well as a summary of the stability test protocol, assuring the product shelf life. 1. General description of how to read the product lot code 1. Photocopy of the product labeling artwork with product data and safety warnings according to the Brazilian cosmetics regulations. 1. Test report proofing the veracity of the product benefits claims, as stated in product labeling. 2. In general, it is demanded for products with some specific benefits claims, such as: antiseptic claims, anti-cellulite claim, skin firming claim, antiwrinkle claim, products with Vitamin C and DMAE, any product to be used around the eyes area, etc. 1. A summary of the safety in use test (in vivo test). A test report showing that the product it is safe to be used in human beings. 2. The safety test can be done by 6 15) Product finality Yes (for products category 1 and 2) 16) Free Sale Yes (for products Certificate (FSC) category 1 and 2) (Must be stamped PS: the original at the Brazilian FSC must be filed with product Embassy or Consulate of the dossier country of origin) 17) Working License (issued by ANVISA) Yes (for products category 1 and 2) Yes (for products category 1 and 2) Yes (for products category 1 and 2) PS: For product Notification and/or Registration to submit only a photocopy of the original FSC. No the manufacturer company, since it is performed according to the test protocols accepted internationally. 3. For lower risk of use products, health authorities will accept simple tests, such as skin cumulative irritation patch tests. 1. Description of product finality. 1. The FSC must be issued by the Ministry of Health or by a local cosmetic trade association since it be certified by the health authorities of the country of origin. 2. Product name stated in the FSC must be the same used in the notification/registration dossier. 1. Must be renewed annually according to the Brazilian sanitary legislation