Regulatory Updates

Distribution date: 07 November 2002

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

Regulation Type: Regular notification

Distribution date: 18 October 2002

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)

Distribution date: 01 October 2002

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

Regulation Type: Regular notification

Distribution date: 30 September 2002

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)

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