Distribution date: 27 September 2002

The following message must appear on any food or food product label containing the additive TARTRAZINA (INS 102), - also known as yellow n.º 5, Food yellow 4 and Acid yellow 23: "Este produto contém o corante TARTRAZINA que pode causar reações alérgicas em pessoas sensíveis". (This product contains the color additive TARTRAZINA which may cause allergic response in susceptible people). Note: Also notified under TBT Agreement

Products Covered: Food additives – tartrazina (INS 102)

Regulation Type: Regular notification

Distribution date: 27 September 2002

This measure aims to establish rules, in order to comply with Resolution RDC n.º 213, previously notified as G/SPS/N/BRA/56/Rev.1. It establishes that, besides the requirements already settled by Brazilian legislation, the importer must present the information listed in Resolution's annexes and fill in the forms contained in it.

Products Covered: Products containing raw material from animal (bovine, ovine, caprine and wild ruminants species) tissues or fluids used to produce drugs, cosmetics and health products. Human tissues, such as blood and its products, pituitary hormones, corneas, bones for grafts and grafts in general. By-products of milk and live animal wool are hereby excluded from the restrictions provisioned for in this Resolution. Food products are also excluded, being subject to specific rules previously notified through G/SPS/N/BRA/55.

Regulation Type: Regular notification

Distribution date: 24 September 2002

Products Covered: Similar, exempt, phytotherapic and new drugs (HS Chapter 30)

Regulation Type: Regular notification

Distribution date: 24 September 2002

Products Covered: Phytotherapic drugs (HS Chapter 30)

Regulation Type: Regular notification

Distribution date: 24 September 2002

Products Covered: New and innovative drugs, with synthetic or semi-synthetic active principles (HS Chapter 30)

Regulation Type: Regular notification

Distribution date: 24 September 2002

Products Covered: Drugs exempt from registration (HS Chapter 30)

Regulation Type: Regular notification

Distribution date: 19 September 2002

Importers of the following products shall report to the Food and Drug Administration (FDA) the amount of the products in possession, use, distribution and transfer. (1) Aristolochia spp. (2) Chloramphenicol (3) Chloroform (4) Chlorpromazine (5) Colchicin (6) Dapsone (7) Nitrofurans (8) Diethylstrillbestrol (9) Sulfonamides (10) Fluroquinolones (11) Glycopeptides (12) Dimetridazole (13) Metronidazole (14) Ronidazole (15) Ipronidazole (16) Medicaments, pharmaceutical products and their salts, and other semi-finished pharmaceutical products in Nitroimidazoles group. Importers who possess, use, distribute and transfer Chloroform shall report to the department of Industrial works, Ministry of Industry.

Products Covered: Pharmaceutical products (HS Chapter 30, ICS: 11.120 Pharmaceutics)

Regulation Type: Regular notification

Distribution date: 19 September 2002

This ministerial notification prescribes that Caffeine and its salts, particularly those which are pharmaceutical products or medicaments containing alkaloids or derivatives thereof, are goods subject to import licensing and export approval. Caffeine derivatives and medicaments which are approved for importation and registration by the Food and Drug Administration, Ministry of Public Health are excluded.

Products Covered: Caffeine and its salts (HS Chapter: 2939.30, ICS: 67.140.20), Medicaments containing alkaloids or derivatives thereof but not containing hormones or other products of heading No. 29.37 or antibiotics (HS Chapter 3003.40)

Regulation Type: Regular notification

Distribution date: 19 September 2002

Application shall be submitted together with (1) documented requests for exportation of such products or certificates of importation issued by the Food and Drug Administration (FDA), Ministry of Public Health or the Department of Industrial works, Ministry of Industry, as the case may be. (2) invoice or proforma invoice or other documented evidence demonstrating trade arrangement

Products Covered: Caffeine and its salts (HS Chapter: 2939.30, ICS: 67.140.20), Medicaments containing alkaloids or derivatives thereof but not containing hormones or other products of heading No. 29.37 or antibiotics (HS Chapter 3003.40)

Regulation Type: Regular notification

Distribution date: 19 September 2002

This ministerial notification prescribes that the following medicaments, pharmaceutical products and their salts, and semi-finished pharmaceutical products are goods subject to import licencing and import prohibition unless approved from the Minister of Commerce or his appointee: (1) Aristolochia spp. (2) Chloramphenicol (3) Chloroform (4) Chlorpromazine (5) Colchicin (6) Dapsone (7) Nitrofurans (8) Diethylstrillbestrol (9) Sulfonamides (10) Fluroquinolones (11) Glycopeptides (12) Dimetridazole (13) Metronidazole (14) Ronidazole (15) Ipronidazole (16) Medicaments, pharmaceutical products and their salts, and other semi-finished pharmaceutical products in Nitroimidazoles group. Importers of such products must be officially approved from the Food and Drug Administration, Ministry of Public Health except for item (3) which must be approved from Department of Industrial works, Ministry of Industry. Such evidences shall be submitted to the Department of Foreign Trade, Ministry of Commerce and shall be approved by the Minister of Commerce or his appointee prior to importation.

Products Covered: Pharmaceutical products (HS Chapter 30, ICS: 11.120 Pharmaceutics)

Regulation Type: Regular notification