Regulatory Updates

Distribution date: 25 November 2020

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Colorcon, Inc., proposing that the color additive regulations be amended to expand the safe use of calcium carbonate to include use in dietary supplement tablets and capsules.

Products Covered: HS Code(s): 2936; ICS Code(s): 67

Regulation Type: Regular notification

Distribution date: 24 November 2020 | Final date for Comment: 09 January 2021

This Draft resolution incorporates the following changes for the active ingredient F66 - FLUBENDIAMIDA (flubendiamide) 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 the potato culture with MRL of 0,01 mg/kg and safety securiy period of 3 days;-includes the caupi bean, chickpea, and lentil cultures with MRL of 0,07 mg/kg and safety security period of 20 days;-changes the MRL from 0,05 to 0,1 mg/kg and the safety security period from 20 to 14 days for the soya culture;-changes the MRL from 0,1 to 0,4 mg/kg and the safety security period from 7 to 3 days for the tomato culture;-changes the MRL from 0,01 to 0,07 mg/kg of the peanut, bean, and pea cultures;-includes the phrase at item "n" : "for the purpose of residue definition for conformity to MRL and dietary risk assessment, it will be considered the active ingredient flubendiamide"

Products Covered: HS Code(s): 1201, 1202, 0701, 071320, 071340, 071390, 0702, 070820, 070810, 07133500; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 24 November 2020 | Final date for Comment: 09 January 2021

This Draft resolution incorporates the following changes for the active ingredient F66 - FLUBENDIAMIDA (flubendiamide) 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 the potato culture with MRL of 0,01 mg/kg and safety securiy period of 3 days;-includes the caupi bean, chickpea, and lentil cultures with MRL of 0,07 mg/kg and safety security period of 20 days;-changes the MRL from 0,05 to 0,1 mg/kg and the safety security period from 20 to 14 days for the soya culture;-changes the MRL from 0,1 to 0,4 mg/kg and the safety security period from 7 to 3 days for the tomato culture;-changes the MRL from 0,01 to 0,07 mg/kg of the peanut, bean, and pea cultures;-includes the phrase at item "n" : "for the purpose of residue definition for conformity to MRL and dietary risk assessment, it will be considered the active ingredient flubendiamide"

Products Covered: HS Code(s): 1201, 1202, 0701, 071320, 071340, 071390, 0702, 070820, 070810, 07133500; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 24 November 2020 | Final date for Comment: 09 January 2021

This Draft resolution incorporates the following changes for the active ingredient D36 - DIFENOCONAZOL (difenoconazole) 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 the pineapple, soursop, cocoa, cupuacu, guarana, kiwi, and pomegranate cultures with MRL of 0,3 mg/kg and safety security period of 3 days;-includes the chard, watercress. witloof chicory, chicory, spinach, stevia reubadiana, mustard, and arugula cultures with MRL of 0,5 mg/kg and safety security period of 14 days;-includes the acerola, blackberry, olive, raspberry, blueberry, Brazilian cherry, and purple mombin cultures with MRL of MRL of 0,5 mg/kg and safety security period of 1 day;-includes the star fruit and mangaba cultures with MRL of 0,5 mg/kg and safety security period of 7 days;-changes the MRL of the fig culture from 0,2 to 0,5 mg/kg;-changes the MRL of the tomato culture from 0,1 to 0,5 mg/kg;-includes the phrase: "for the purpose of residue definition for conformity to MRL and dietary risk assessment, it will be considered the active ingredient difenoconazole"

Products Covered: HS Code(s): 18, 120750, 0804, 07052, 070970, 070992, 0810, 0702, 081090, 3295, 08105000, 08109090, 12099110, 070990, 12119029, 0709999000, 080920, 081040, 081190, 071430, 081090,  cupuacu, mangaba; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 24 November 2020 | Final date for Comment: 09 January 2021

This Draft resolution incorporates the following changes for the active ingredient D36 - DIFENOCONAZOL (difenoconazole) 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 the pineapple, soursop, cocoa, cupuacu, guarana, kiwi, and pomegranate cultures with MRL of 0,3 mg/kg and safety security period of 3 days;-includes the chard, watercress. witloof chicory, chicory, spinach, stevia reubadiana, mustard, and arugula cultures with MRL of 0,5 mg/kg and safety security period of 14 days;-includes the acerola, blackberry, olive, raspberry, blueberry, Brazilian cherry, and purple mombin cultures with MRL of MRL of 0,5 mg/kg and safety security period of 1 day;-includes the star fruit and mangaba cultures with MRL of 0,5 mg/kg and safety security period of 7 days;-changes the MRL of the fig culture from 0,2 to 0,5 mg/kg;-changes the MRL of the tomato culture from 0,1 to 0,5 mg/kg;-includes the phrase: "for the purpose of residue definition for conformity to MRL and dietary risk assessment, it will be considered the active ingredient difenoconazole"

Products Covered: HS Code(s): 18, 120750, 0804, 07052, 070970, 070992, 0810, 0702, 081090, 3295, 08105000, 08109090, 12099110, 070990, 12119029, 0709999000, 080920, 081040, 081190, 071430, 081090,  cupuacu, mangaba; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 24 November 2020 | Final date for Comment: 09 January 2021

This Draft resolution incorporates the following changes for the active ingredient C58 - ALFA-CIPERMETRINA (alpha-cypermethrin) 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 the cotton culture with MRL of 0,15 mg/kg and safety security period of 14 days;-includes the peanut culture with MRL of 0,05 mg/kg and safety security period of 15 days;-includes the rice culture with 2,0 mg/kg and safety security period of 14 days;-includes the potato culture with safety security period of 3 days;-includes the cane sugar culture with safety security period of 189 days;-includes the bean culture with safety security period of 15 days;-includes the tomato culture with safety security period of 1 day;-includes the phrase: Acceptable Daily Intake (ADI) : 0,02 mg/kg b.w. (source: JMPR 2006);-includes the phrase: Acute Reference Dose (ARfD) : 0,04 mg/kg b.w. (source: JMPR 2006).

Products Covered: HS Code(s): 52, 1006, 170113, 200811, 0701, 0702, 07133; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 24 November 2020 | Final date for Comment: 09 January 2021

This Draft resolution incorporates the following changes for the active ingredient C58 - ALFA-CIPERMETRINA (alpha-cypermethrin) 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 the cotton culture with MRL of 0,15 mg/kg and safety security period of 14 days;-includes the peanut culture with MRL of 0,05 mg/kg and safety security period of 15 days;-includes the rice culture with 2,0 mg/kg and safety security period of 14 days;-includes the potato culture with safety security period of 3 days;-includes the cane sugar culture with safety security period of 189 days;-includes the bean culture with safety security period of 15 days;-includes the tomato culture with safety security period of 1 day;-includes the phrase: Acceptable Daily Intake (ADI) : 0,02 mg/kg b.w. (source: JMPR 2006);-includes the phrase: Acute Reference Dose (ARfD) : 0,04 mg/kg b.w. (source: JMPR 2006).

Products Covered: HS Code(s): 52, 1006, 170113, 200811, 0701, 0702, 07133; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 24 November 2020 | Final date for Comment: 09 January 2021

This Draft resolution incorporates the following changes for the active ingredient A38 - ACIBENZOLAR-S-METÍLICO (acibenzolar-S-methyl) 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 the acai, Brazil nuts, palm nuts, macadamia nuts, pecan nuts, pine nuts, and peach palm cultures with MRL of 0,2 mg/kg and safety security period of 1 day;-includes the pumpkin, zucchini, chayote, and gherkin cultures with MRL of 0,5 mg/kg and safety security period of 5 days;-includes the garlic and shallot cultures with MRL of 0,01 mg/kg and safety security period of 7 days; -includes the sweet potatoes, yacon, beetroot, greater yams, carrot, ginger, yams, manioc, arracacha, turnip, and radish cultures with MRL 0,1 mg/kg and safety security period of 14 days; -includes the duboisia culture with MRL and safety security period of "Non-food use";-includes the phrase: "I) Acute Reference Dose (ARfD) : 0,5 mg/kg b.w. (source: JMPR*, 2016)".-includes the phrase: "*The Joint FAO/WHO Meeting on Pesticide Residues"

Products Covered: HS Code(s): 1106, 120710, 08012, 08026, 070993, 0707, 0703, 0706, 09101, 08029010, 08029000, 0810909050, 07096090, 0709991000, 17029040000, 07143000, 071430, 0714900011, acai, duboisia; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 24 November 2020 | Final date for Comment: 09 January 2021

This Draft resolution incorporates the following changes for the active ingredient A38 - ACIBENZOLAR-S-METÍLICO (acibenzolar-S-methyl) 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 the acai, Brazil nuts, palm nuts, macadamia nuts, pecan nuts, pine nuts, and peach palm cultures with MRL of 0,2 mg/kg and safety security period of 1 day;-includes the pumpkin, zucchini, chayote, and gherkin cultures with MRL of 0,5 mg/kg and safety security period of 5 days;-includes the garlic and shallot cultures with MRL of 0,01 mg/kg and safety security period of 7 days; -includes the sweet potatoes, yacon, beetroot, greater yams, carrot, ginger, yams, manioc, arracacha, turnip, and radish cultures with MRL 0,1 mg/kg and safety security period of 14 days; -includes the duboisia culture with MRL and safety security period of "Non-food use";-includes the phrase: "I) Acute Reference Dose (ARfD) : 0,5 mg/kg b.w. (source: JMPR*, 2016)".-includes the phrase: "*The Joint FAO/WHO Meeting on Pesticide Residues"

Products Covered: HS Code(s): 1106, 120710, 08012, 08026, 070993, 0707, 0703, 0706, 09101, 08029010, 08029000, 0810909050, 07096090, 0709991000, 17029040000, 07143000, 071430, 0714900011, acai, duboisia; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 24 November 2020 | Final date for Comment: 09 January 2021

This Draft resolution incorporates the following changes for the active ingredient C70 - CLORANTRANILIPROLE (Chlorantraniliprole) 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 the sweet potato, beetroot, carrot, manioc, and arracacha cultures with MRL of 0,15 mg/kg and safety security period 7 days.

Products Covered: HS Code(s): 071420, 0706, 071410, 0714900011; ICS Code(s): 13, 65

Regulation Type: Regular notification