Regulatory Updates

Resolution – RDC number 389 number, May 26th, 2020.

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Distribution date: 25 August 2020

This resolution establishes temporary requirements for the characterisation and risk verification of the decrease in the supply of medicines during the coronavirus pandemic.

Products Covered: Antibiotics. (HS code(s): 2941); Medicaments (excluding goods of heading No. 3002, 3005 or 3006) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or informs or packings for retail sale. (HS code(s): 3003); Medicaments (excluding goods of heading No. 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale. (HS code(s): 3004); Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes. (HS code(s): 3005); Pharmaceutical goods specified in Note 3 to this Chapter. (HS code(s): 3006)

Regulation Type: Regular notification

E09. COVID-19 TBT

Resolution – RDC number 389 number, May 26th, 2020.

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Distribution date: 25 August 2020

This resolution establishes temporary requirements for the characterisation and risk verification of the decrease in the supply of medicines during the coronavirus pandemic.

Products Covered: Antibiotics. (HS code(s): 2941); Medicaments (excluding goods of heading No. 3002, 3005 or 3006) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or informs or packings for retail sale. (HS code(s): 3003); Medicaments (excluding goods of heading No. 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale. (HS code(s): 3004); Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes. (HS code(s): 3005); Pharmaceutical goods specified in Note 3 to this Chapter. (HS code(s): 3006)

Regulation Type: Regular notification

E09. COVID-19 TBT

Letter of the Federal Service for the Veterinary and Phytosanitary Surveillance No. FS-ARE-7/3477-3 of 10 August 2020.

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Distribution date: 21 August 2020

This letter introduced a temporary restriction on import of live poultry, bird's eggs and other poultry products from Bulgaria due to complicated epizootic situation with Newcastle disease.

Products Covered: Live poultry, bird's eggs and other poultry products. 

Regulation Type: Emergency notifications (SPS)

Animal diseases Animal health Pest- or Disease- free Regions / Regionalization Newcastle Disease Zoonoses

Letter of the Federal Service for the Veterinary and Phytosanitary Surveillance No. FS-ARE-7/3477-3 of 10 August 2020.

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Distribution date: 21 August 2020

This letter introduced a temporary restriction on import of live poultry, bird's eggs and other poultry products from Bulgaria due to complicated epizootic situation with Newcastle disease.

Products Covered: Live poultry, bird's eggs and other poultry products. 

Regulation Type: Emergency notifications (SPS)

Animal diseases Animal health Pest- or Disease- free Regions / Regionalization Newcastle Disease Zoonoses

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)

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Distribution date: 21 August 2020 | Final date for Comment: 20 October 2020

Proposed maximum residue limits (MRLs) for the following agricultural chemical Pesticide/ Veterinary drug: Oxolinic Acid

Products Covered: -Meat and edible meat offal (HS: 02.01, 02.02, 02.03, 02.06, 02.07 and 02.09) -Fish and crustaceans (HS: 03.02, 03.03, 03.04 and 03.06) -Animal originated products (HS: 05.04) -Edible vegetables and certain roots and tubers (HS: 07.01, 07.03, 07.04, 07.05, 07.06, 07.09, 07.10 and 07.14) -Edible fruit (HS: 08.08, 08.09 and 08.11) -Tea and spices (HS: 09.02, 09.10) -Cereals (HS: 10.05 and 10.06)-Animal fats and oils (HS: 15.01 and 15.02)

Regulation Type: Regular notification

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

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)

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Distribution date: 21 August 2020 | Final date for Comment: 20 October 2020

Proposed maximum residue limits (MRLs) for the following agricultural chemical Pesticide/ Veterinary drug: Oxolinic Acid

Products Covered: -Meat and edible meat offal (HS: 02.01, 02.02, 02.03, 02.06, 02.07 and 02.09) -Fish and crustaceans (HS: 03.02, 03.03, 03.04 and 03.06) -Animal originated products (HS: 05.04) -Edible vegetables and certain roots and tubers (HS: 07.01, 07.03, 07.04, 07.05, 07.06, 07.09, 07.10 and 07.14) -Edible fruit (HS: 08.08, 08.09 and 08.11) -Tea and spices (HS: 09.02, 09.10) -Cereals (HS: 10.05 and 10.06)-Animal fats and oils (HS: 15.01 and 15.02)

Regulation Type: Regular notification

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

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)

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Distribution date: 21 August 2020

Proposed maximum residue limits (MRLs) for the following agricultural chemical Pesticide: Tolpyralate

Products Covered: -Cereals (HS: 10.05)

Regulation Type: Regular notification

Food safety Human health Maximum residue limits (MRLs) Pesticides

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)

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Distribution date: 21 August 2020

Proposed maximum residue limits (MRLs) for the following agricultural chemical Pesticide: Tolpyralate

Products Covered: -Cereals (HS: 10.05)

Regulation Type: Regular notification

Food safety Human health Maximum residue limits (MRLs) Pesticides

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)

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Distribution date: 21 August 2020

Proposed maximum residue limits (MRLs) for the following agricultural chemical Pesticide: Imazapyr

Products Covered: -Meat and edible meat offal (HS: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) -Dairy produce and birds' eggs (HS: 04.01, 04.07 and 04.08) -Animal originated products (HS: 05.04) -Edible vegetables and certain roots and tubers (HS: 07.10 and 07.13) -Cereals (HS: 10.01, 10.03 and 10.05) -Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS: 12.01, 12.05 and 12.06)-Animal fats and oils (HS: 15.01, 15.02 and 15.06)

Regulation Type: Regular notification

Maximum residue limits (MRLs) Human health Pesticides Food safety

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)

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Distribution date: 21 August 2020

Proposed maximum residue limits (MRLs) for the following agricultural chemical Pesticide: Imazapyr

Products Covered: -Meat and edible meat offal (HS: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) -Dairy produce and birds' eggs (HS: 04.01, 04.07 and 04.08) -Animal originated products (HS: 05.04) -Edible vegetables and certain roots and tubers (HS: 07.10 and 07.13) -Cereals (HS: 10.01, 10.03 and 10.05) -Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS: 12.01, 12.05 and 12.06)-Animal fats and oils (HS: 15.01, 15.02 and 15.06)

Regulation Type: Regular notification

Maximum residue limits (MRLs) Human health Pesticides Food safety

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