Revision of the substances having no potential to cause damage to human health that the provision requires the Minister of MHLW to specify under the Food Sanitation Act (Final rule)

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Distribution date: 27 March 2019

Designation of the following agricultural chemicals as substances having no potential to cause damage to human health, which is also referred to as "exempt substance," based on the provision of Paragraph 3, Article 11 of the Food Sanitation Act: Pesticide: Glyceryl caprylate.

Products Covered: -Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) -Fish and crustaceans, molluscs and other aquatic invertebrates (HS Codes: 03.02, 03.03, 03.04, 03.06 and 03.07) -Dairy produce, birds' eggs and natural honey (HS Codes: 04.01, 04.07 and 04.08) -Products of animal origin (HS Code: 05.04) -Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14) -Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) -Coffee, tea, mate and spices (HS Codes: 09.01, 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) -Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) -Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02, 12.04, 12.05, 12.06, 12.07, 12.10 and 12.12) -Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06)-Cacao and cacao preparations (HS Code: 18.01)

Regulation Type: Regular notification

Food safety Human health Pesticides

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

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Distribution date: 27 March 2019

Maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Fluxametamide.

Products Covered: - Fish and crustaceans, molluscs and other aquatic invertebrates (HS Codes: 03.02, 03.03 and 03.04) - Edible vegetables and certain roots and tubers (HS Codes: 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10 and 07.14) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.07, 08.10 and 08.11) - Coffee, tea, mate and spices (HS Codes: 09.02 and 09.03)- Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Code: 12.01)

Regulation Type: Regular notification

Food additives Maximum residue limits (MRLs) Food safety Human health Pesticides

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

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Distribution date: 27 March 2019

Maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Fluxametamide.

Products Covered: - Fish and crustaceans, molluscs and other aquatic invertebrates (HS Codes: 03.02, 03.03 and 03.04) - Edible vegetables and certain roots and tubers (HS Codes: 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10 and 07.14) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.07, 08.10 and 08.11) - Coffee, tea, mate and spices (HS Codes: 09.02 and 09.03)- Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Code: 12.01)

Regulation Type: Regular notification

Food additives Maximum residue limits (MRLs) Food safety Human health Pesticides

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

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Distribution date: 27 March 2019

Maximum residue limits (MRLs) for the following agricultural chemical: Veterinary drug: Monepantel.

Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.04, 02.05, 02.06 and 02.08)- Products of animal origin (HS Code: 05.04)- Animal or vegetable fats and oils (HS Codes: 15.02 and 15.06)

Regulation Type: Regular notification

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

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

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Distribution date: 27 March 2019

Maximum residue limits (MRLs) for the following agricultural chemical: Veterinary drug: Monepantel.

Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.04, 02.05, 02.06 and 02.08)- Products of animal origin (HS Code: 05.04)- Animal or vegetable fats and oils (HS Codes: 15.02 and 15.06)

Regulation Type: Regular notification

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

Draft resolution number 624, 14 March 2019, regarding the active ingredient C40 – CLORFENAPIR (chlorfenapyr) of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE n° 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003

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Distribution date: 26 March 2019 | Final date for Comment: 16 May 2019

This Draft resolution incorporates the following changes for the active ingredient C40 – CLORFENAPIR (chlorfenapyr) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application): - includes peanut culture with MRL of 0.1 mg/kg and safety security period of 14 days.

Products Covered: HS Code(s): 0802; ICS Code(s): 13, 65

Regulation Type: Regular notification

Maximum residue limits (MRLs) Food safety Human health Pesticides

Draft resolution number 624, 14 March 2019, regarding the active ingredient C40 – CLORFENAPIR (chlorfenapyr) of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE n° 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003

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Distribution date: 26 March 2019 | Final date for Comment: 16 May 2019

This Draft resolution incorporates the following changes for the active ingredient C40 – CLORFENAPIR (chlorfenapyr) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application): - includes peanut culture with MRL of 0.1 mg/kg and safety security period of 14 days.

Products Covered: HS Code(s): 0802; ICS Code(s): 13, 65

Regulation Type: Regular notification

Maximum residue limits (MRLs) Food safety Human health Pesticides

Draft resolution number 628, 14 March 2019, regarding the active ingredient M32 – METOXIFENOZIDA (methoxyfenozide) of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE n° 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003

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Distribution date: 26 March 2019 | Final date for Comment: 16 May 2019

This Draft resolution incorporates the following changes for the active ingredient M32 – METOXIFENOZIDA (methoxyfenozide) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application): - includes coffee culture with MRL of 0.15 mg/kg and safety security period of 7 days; - includes sugar cane culture with MRL of 0.03 mg/kg and safety security period of 60 days.

Products Covered: HS Code(s): 0901, 1212; ICS Code(s): 13, 65

Regulation Type: Regular notification

Maximum residue limits (MRLs) Human health Pesticides Food safety

Draft resolution number 628, 14 March 2019, regarding the active ingredient M32 – METOXIFENOZIDA (methoxyfenozide) of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE n° 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003

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Distribution date: 26 March 2019 | Final date for Comment: 16 May 2019

This Draft resolution incorporates the following changes for the active ingredient M32 – METOXIFENOZIDA (methoxyfenozide) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application): - includes coffee culture with MRL of 0.15 mg/kg and safety security period of 7 days; - includes sugar cane culture with MRL of 0.03 mg/kg and safety security period of 60 days.

Products Covered: HS Code(s): 0901, 1212; ICS Code(s): 13, 65

Regulation Type: Regular notification

Maximum residue limits (MRLs) Human health Pesticides Food safety

Draft resolution number 630, 14 March 2019, regarding the active ingredient E19 – ETOFENPROXI (etofenprox) of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE n° 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003

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Distribution date: 26 March 2019 | Final date for Comment: 16 May 2019

This Draft resolution incorporates the following changes for the active ingredient E19 – ETOFENPROXI (etofenprox) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application): - includes sunflower, canola and castor beans cultures with MRL of 0.04 mg/kg and safety security period of 7 days;- includes beet, carrot, manioc and little cassava cultures with MRL of 0.01 mg/kg and safety security period of 7 days;- changes the frase at item "j": "for the purpose of residue definition for conformity with MRL it will be considered the active ingridient etofenprox, and for the dietary risk assessment: etofenprox and its metabolite a-CO, expressed as etofenprox".

Products Covered: HS Code(s): 0602, 0706, 0714; ICS Code(s): 13, 65

Regulation Type: Regular notification

Food safety Human health Pesticides Maximum residue limits (MRLs)

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