Regulatory Updates

Distribution date: 01 December 2015 | Final date for Comment: 30 January 2016

Due to the inconsistencies with the current situation from emerging disease, it is deemed appropriate to repeal Pathogen and Animal Toxin Act B.E. 2525 and B.E.2544 and establish the Pathogen and Animal Toxin Act B.E. 2558. The new Act has been amended as follows: 1. Establishing the Committee on Pathogen and Animal Toxin; 2. Authorizing the Minister of Public Health to issue the regulations, rules, procedures, and conditions to protect and prevent public health from Pathogen and Animal Toxin; 3. Amending the regulatory controls on manufacturing, distribution, possession, importation, exportation or transit, and transportation of Pathogen and Animal Toxin in accordance with WHO by classifying the risk group; 4. Amending the provision on civil liability and penalty; 5. Amending the provision on administrative fees. The measure is based on a WHO Standard as follows: 1. World Health Organization - Laboratory Biosafety Manual - Third Edition, 2004; 2. Guidance on regulations for the Transport of Infectious Substances 2013-2014.

Products Covered: 1) Micro-organism and product thereof, that cause of disease in Human being and Livestock animal; 2) Animal toxin, that harm to Human and Livestock animal; 3) Biological agent and Product of animal toxin, that cause of disease in Human being and Livestock animal (HS Code: 3002.90.00)

Regulation Type: Regular notification

Distribution date: 01 December 2015 | Final date for Comment: 30 January 2016

Due to the inconsistencies with the current situation from emerging disease, it is deemed appropriate to repeal Pathogen and Animal Toxin Act B.E. 2525 and B.E.2544 and establish the Pathogen and Animal Toxin Act B.E. 2558. The new Act has been amended as follows: 1. Establishing the Committee on Pathogen and Animal Toxin; 2. Authorizing the Minister of Public Health to issue the regulations, rules, procedures, and conditions to protect and prevent public health from Pathogen and Animal Toxin; 3. Amending the regulatory controls on manufacturing, distribution, possession, importation, exportation or transit, and transportation of Pathogen and Animal Toxin in accordance with WHO by classifying the risk group; 4. Amending the provision on civil liability and penalty; 5. Amending the provision on administrative fees. The measure is based on a WHO Standard as follows: 1. World Health Organization - Laboratory Biosafety Manual - Third Edition, 2004; 2. Guidance on regulations for the Transport of Infectious Substances 2013-2014.

Products Covered: 1) Micro-organism and product thereof, that cause of disease in Human being and Livestock animal; 2) Animal toxin, that harm to Human and Livestock animal; 3) Biological agent and Product of animal toxin, that cause of disease in Human being and Livestock animal (HS Code: 3002.90.00)

Regulation Type: Regular notification

Distribution date: 01 December 2015

Interministerial Ordinance nº 701, 31 August 2015, regarding a monetary update on registration and GMP certification fees related to health products in Brazil. This Ordinance promoted a monetary update on registration and GMP certification fees related to health products in Brazil. It was necessary once the values of ANVISA's fees were obsolete since its creation in 1999, with accumulated losses of 193.5% according to Brazilian official inflation rate. So it is considered not to be a tribute increase, but a currency value reconstitution.

Products Covered: Monetary update on registration and GMP certification fees related to health products

Regulation Type: Regular notification

Distribution date: 01 December 2015

Interministerial Ordinance nº 701, 31 August 2015, regarding a monetary update on registration and GMP certification fees related to health products in Brazil. This Ordinance promoted a monetary update on registration and GMP certification fees related to health products in Brazil. It was necessary once the values of ANVISA's fees were obsolete since its creation in 1999, with accumulated losses of 193.5% according to Brazilian official inflation rate. So it is considered not to be a tribute increase, but a currency value reconstitution.

Products Covered: Monetary update on registration and GMP certification fees related to health products

Regulation Type: Regular notification

Distribution date: 25 November 2015 | Final date for Comment: 24 January 2016

This standard applies to food additive Purple Sweet Potato Pigment obtained by leaching and extracting of tuberous roots of the sweet potato plant (Ipomoea batatas (L.) Lam.) with acidic water (such as citric acid) or ethanol water. It stipulates the technical requirements and test methods for food additive Purple Sweet Potato Pigment.

Products Covered: Food additive Purple Sweet Potato Pigment

Regulation Type: Regular notification

Distribution date: 25 November 2015 | Final date for Comment: 24 January 2016

This standard applies to food additive Purple Sweet Potato Pigment obtained by leaching and extracting of tuberous roots of the sweet potato plant (Ipomoea batatas (L.) Lam.) with acidic water (such as citric acid) or ethanol water. It stipulates the technical requirements and test methods for food additive Purple Sweet Potato Pigment.

Products Covered: Food additive Purple Sweet Potato Pigment

Regulation Type: Regular notification

Distribution date: 24 November 2015 | Final date for Comment: 05 February 2016

This Code covers relevant practices during primary production, primary processing (i.e. wet and dry), and storage and transport of green coffee beans to ensure food safety and sustainability of coffee production. This Code concentrates on addressing microbial and chemical hazards and addresses physical hazards only in so far as these relates to GAPs and GMPs, and provides specific guidance on how to minimize these hazards. This Code, however, does not provide recommendations on food safety practices for the processing of green coffee beans into its ground, blended, or ready-to-drink form; or its subsequent storage, transport and handling practices at wholesale, retail and food service or at home.

Products Covered: HS Code(s): 08

Regulation Type: Regular notification

Distribution date: 24 November 2015 | Final date for Comment: 05 February 2016

This Code covers relevant practices during primary production, primary processing (i.e. wet and dry), and storage and transport of green coffee beans to ensure food safety and sustainability of coffee production. This Code concentrates on addressing microbial and chemical hazards and addresses physical hazards only in so far as these relates to GAPs and GMPs, and provides specific guidance on how to minimize these hazards. This Code, however, does not provide recommendations on food safety practices for the processing of green coffee beans into its ground, blended, or ready-to-drink form; or its subsequent storage, transport and handling practices at wholesale, retail and food service or at home.

Products Covered: HS Code(s): 08

Regulation Type: Regular notification

Distribution date: 24 November 2015 | Final date for Comment: 05 February 2016

This standard covers general practices for the production and primary processing of papaya cultivated for human consumption, particularly those that will be consumed fresh whether in its whole or fresh-cut form; or those that will be further processed. Specifically, this Code is applicable to papaya that is field grown. It concentrates on microbial and chemical hazards and addresses physical hazards only in which can be related to Good Agricultural Practices (GAP) and Good Manufacturing Practices (GMP) during primary production and minimal processing of the commodity. This Code does not provide recommendations on handling practices to maintain the safety of papaya at wholesale, retail, and food services or in the home.

Products Covered: HS Code(s): 08

Regulation Type: Regular notification

Distribution date: 24 November 2015 | Final date for Comment: 05 February 2016

This standard covers general practices for the production and primary processing of papaya cultivated for human consumption, particularly those that will be consumed fresh whether in its whole or fresh-cut form; or those that will be further processed. Specifically, this Code is applicable to papaya that is field grown. It concentrates on microbial and chemical hazards and addresses physical hazards only in which can be related to Good Agricultural Practices (GAP) and Good Manufacturing Practices (GMP) during primary production and minimal processing of the commodity. This Code does not provide recommendations on handling practices to maintain the safety of papaya at wholesale, retail, and food services or in the home.

Products Covered: HS Code(s): 08

Regulation Type: Regular notification