Draft Resolution number 63, August 12th, 2002 (Consulta Pública no. 63 de 12 de agosto de 2002) issued by the Brazilian Sanitary Surveillance Agency on technical procedures which apply to similar, exempt, phytotherapic and new drugs. (6 pages, in Portuguese).

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Distribution date: 24 September 2002 | Final date for Comment: 26 April 2025

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

Regulation Type: Regular notification

Resolution RDC n.º 214, dated 30 July 2002 (5 pages), published in the Federal Official Journal (Diário Oficial da União) on 20 August 2002 (Available in Portuguese at http://www.anvisa.gov.br/legis/resol/2002/214_02rdc.htm)

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Distribution date: 27 September 2002 | Final date for Comment: 26 April 2025

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

Human health Pharmaceutical products

Consulta Pública (Draft Resolution) n.º 68, dated 22 August 2002. Published in the Federal Official Journal (Diário Oficial da União) on 23 August 2002 (1 page) (Available in Portuguese)

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Distribution date: 27 September 2002 | Final date for Comment: 26 April 2025

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

Food safety Labelling Human health Food additives

Resolution RDC nº 213, dated 30 July 2002 (7 pages), published in the Federal Official Journal (Diário Oficial da União) on 2 August 2002 (Available in Portuguese at http://www.anvisa.gov.br/legis/resol/2002/213_02rdc.htm)

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Distribution date: 30 September 2002 | Final date for Comment: 26 April 2025

This measure defines the requirements to countries that want to export the above-mentioned products to Brazil, according to their geographical risk and to the tissue infectivity level of the exported product. This rule reinforces the prohibition, throughout the Brazilian territory, of the entrance, trade and display of the above-mentioned products that come from countries of certain regions, according the classification specified in the notified Resolution. The Resolution RDC nº 213 replaces Resolution RDC nº 118, previously notified as G/SPS/N/BRA/56.

Products Covered:

Regulation Type: Emergency notifications (SPS)

Human health Animal diseases Pharmaceutical products Transmissible Spongiform Encephalopathy (TSE) Zoonoses Bovine Spongiform Encephalopathy (BSE)

Draft Resolution number 68, August 22th, 2002 (Consulta Pública no. 68 de 22 de agosto de 2002) issued by the Brazilian Sanitary Surveillance Agency on labelling requirements for tartrazine containing foods. (1 page, in Portuguese).

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Distribution date: 01 October 2002 | Final date for Comment: 26 April 2025

Products Covered: Food and food additives (HS Section 4, Chapters 28 and 29)

Regulation Type: Regular notification

Food standards

- Newsletter No. 78 - Directive of the Swiss Federal Office for Public Health: New Maximum Limits for Nitrofuran Residues in Foodstuffs of Animal Origin (three pages, in French and German).

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Distribution date: 18 October 2002 | Final date for Comment: 26 April 2025

1. The active substances listed below are subject, as of 13 August 2002, to the following maximum residue limits (MRLs): 1 2 3 4 5 6 Active substance Scope Foodstuff Tolerance value mg/kg Maximum residue limit (MRL) mg/kg Comments Furaltadone C Meat 0.001 Sum of the furaltadone and its metabolites with an intact 5-nitrofuran and 3-amino-5-morpholinomethyl-2-oxazolidinone (AMOZ) side chain; calculated as furaltadone Furazolidone C Meat 0.001 Sum of the furazolidone and its metabolites with an intact 5-nitrofuran and 3-amino-2-oxazolidinone (AOZ) side chain; calculated as furazolidone Nitrofurantoin C Meat 0.001 Sum of the nitrofurantoin and its metabolites with an intact 5-nitrofuran and 1-aminohydantoin (AHD) side chain; calculated as nitrofurantoin Nitrofurazone C Meat 0.001 Sum of the nitrofurazone and its metabolites with an intact 5-nitrofuran and semicarbazide (SEM) side chain; calculated as nitrofurazone 2. The tolerance value for furazolidone in list 3 of the Annex to the Ordinance on Foreign Substances and Toxic Components in Foodstuffs is hereby removed with immediate effect.

Products Covered: Foodstuffs of animal origin

Regulation Type: Emergency notifications (SPS)

Veterinary drugs Human health Maximum residue limits (MRLs) Food safety

Revision of Cosmetic Regulation under the Pharmaceutical Affairs Law. (available in English, 1 page)

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Distribution date: 07 November 2002 | Final date for Comment: 26 April 2025

Products Covered: Cosmetics (HS:  30.03, 33.04, 33.05, 33.06, 33.07, 34.01)

Regulation Type: Regular notification

Amendment of the Official Standards for Ordinary Fertilizers (4 pages, available in English)

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Distribution date: 19 November 2002 | Final date for Comment: 26 April 2025

Products Covered: Fertilizer (HS: 3103, 3105)

Regulation Type: Regular notification

Partial Amendment of Agricultural Chemicals Regulation Law (available in English, 1 page).

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Distribution date: 27 November 2002 | Final date for Comment: 26 April 2025

Under the existing law, importers and manufacturers of agricultural chemicals are required to register agricultural chemicals with the Minister of Agriculture, Forestry and Fisheries before they sell those chemicals to Japan. After the amendment, in order to prevent distribution of un-registered agricultural chemicals, importers will be required to register the agriculture chemicals before they import them.

Products Covered: Agricultural Chemicals (HS:3208 imported agricultural chemicals)

Regulation Type: Emergency notifications (SPS)

Food safety Human health Pesticides

"Draft of Scope and Application Standards of Food Additives: 8. Nutritional Additives" (available in English, 12 pages).

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Distribution date: 02 December 2002 | Final date for Comment: 26 April 2025

1. The upper limits of these nutritional additives mentioned in item 3 in foods are regulated as 150 per cent of the recommended daily nutrient allowances (RDNAs). General foods are calculated on basis of the RDNA for 16-year-old male, and infant (supplementary) foods are calculated on basis of the RDNA for one-year-old infant. 2. The RDNAs in the Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu have been reviewed and revised as "Dietary Reference Intakes, DRIs" on 15 October 2002. The application standards of these nutritional additives are accommodatingly amended. Considering the convenience for reading, the actual upper limits calculated from the data of DRIs are listed explicitly to replace the original description. 3. The Application standards for other specific foods, such as those foods in capsule or tablet form, and edible salts, are not amended.

Products Covered: The following nutritional additives: vitamin A, B1, B2, B6, B12, C, D, E, niacin, folic acid, compounds containing calcium, iron, iodine.

Regulation Type: Regular notification

Food safety Human health

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