Regulatory Updates

Distribution date: 18 January 2021

This letter introduces a temporary restriction on import of life poultry and poultry products from Lithuania due to the outbreak of highly pathogenic avian influenza.

Products Covered: Live poultry and hatching egg, poultry meat and poultry processed products not heat-treated, feeds and feed additives for poultry (with the exception of feed additives of vegetable origin, chemical and microbiological synthesis), used equipment and supplies for transportation, breeding, stockkeeping, slaughtering and cutting of poultry HS Codes: of 0105, of 0106, of 0207, of 0208, of 0209, of 0210, of 0407, of 0408, of 0410000000, of 0510000000, of 0504000000, of 0505, of 0507, of 1501, of 0511, of 150300, of 1506000000, of 151610, of 151800, of 160100, of 1602, of 160300, of 190220, of 190420, of 2104, of 2106, of 2309, of 2301, of 2309, of 3101000000, of 3502, of 350400, of 3507, of 4206000000, of 9508100000, of 9705000000

Regulation Type: Emergency notifications (SPS)

Distribution date: 14 January 2021

The notified Regulation establishes the regulatory provisions of Article 8 of Law No. 29459 - Law on pharmaceutical products, medical devices and sanitary products, amended by Law No. 31091, to regulate the conditional sanitary registration of medicines and biological products with phase III clinical studies.

Products Covered: Pharmaceutical products classified under Chapter 30 of the Harmonized System or Customs Tariff

Regulation Type: Regular notification

Distribution date: 14 January 2021 | Final date for Comment: 20 February 2021

This Draft resolution incorporates the following changes for the active ingredient C30 - CIFLUTRINA (cyfluthrin) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application):- changes the MRL of the cotton culture from 0.01 to 0.1 mg/kg;- changes the MRL of the peanut culture from 0.01 to 0.1 mg/kg;- changes the MRL of the rice culture from 0.01 to 0.1 mg/kg;- changes the MRL of the coffe culture from 0.01 to 0.05 mg/kg;- changes the MRL of the bean culture from 0.01 to 0.1 mg/kg;- changes the MRL of the corn culture from 0.01 to 0.05 mg/kg;- changes the MRL of the soya culture from 0.01 to 0.1 mg/kg;- changes the MRL of the tomato culture from 0.02 to 0.2 mg/kg;- changes the MRL of the wheat culture from 0.01 to 0.05 mg/kg;- includes the phrase: "m) Acute Reference Dose (ARfD): 0.04 mg/kg b.w. (source: JMPR*, 2007);- includes the phrase: "*The Joint FAO/WHO Meeting on Pesticide Residues";- includes the phrase: "n) for the purpose of residue definition for conformity to MRL and dietary risk assessment, it will be considered the active ingredient cyfluthrin and the sum of its isomers".

Products Covered: HS Code(s): 52, 1001, 1005, 1006, 1201, 1202, 20081, 09, 07133, 0701; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 14 January 2021 | Final date for Comment: 20 February 2021

This Draft resolution incorporates the following changes for the active ingredient D06 - DELTAMETRINA (deltamethrin) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers:- includes the sorghum culture with MRL of 1.0 mg/kg and safety security period of 30 days in the modality of stored products use (application);- changes the MRL of the sorghum culture from 0.05 to 1.0 mg/kg in the modality of foliar use (application);- includes the phrase: "*The Joint FAO/WHO Meeting on Pesticide Residues";- includes the phrase: "m) for the purpose of residue definition for conformity to MRL and dietary risk assessment, it will be considered the active ingredient deltamethrin".

Products Covered: HS Code(s): 1007; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 14 January 2021 | Final date for Comment: 20 February 2021

This Draft resolution incorporates the following changes for the active ingredient S09 – SULFENTRAZONA (sulfentrazone) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of pre emergency use (application):- includes the peanut culture with MRL of 0.01 mg/kg and safety security period "Not determined";- includes the phrase: "Acute Reference Dose (ARfD): 0.025 mg/kg b.w. (women of reproductive age). Source: EPA*, 2009;- includes the phrase: "*United States Environmental Protection Agency".

Products Covered: HS Code(s): 1202, 20081; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 14 January 2021 | Final date for Comment: 20 February 2021

This Draft resolution incorporates the following changes for the active ingredient A53 – AMINOPIRALIDE (aminopyralid) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modalities of pre and post emergency use (application):- includes the cane sugar culture with MRL of 0.01 mg/kg and safety security period "Not determined due to the pre and post emergency use of the pesticide until three months after the planting or harvest";- includes the phrase: "Acute Reference Dose (ARfD): 0.26 mg/kg b.w. (source: EFSA*, 2013);- includes the phrase: "*European Food Safety Authority".

Products Covered: HS Code(s): 1701; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 14 January 2021 | Final date for Comment: 20 February 2021

This Draft resolution incorporates the following changes for the active ingredient C64 – CLOTIANIDINA (clothianidin) 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 corn culture with safety security period of 21 days;- includes the phrase: "l) Acute Reference Dose (ARfD): 0.6 mg/kg b.w. (source: JMPR*, 2010);- includes the phrase: "*The Joint FAO/WHO Meeting on Pesticide Residues";- includes the phrase: "m) for the purpose of residue definition for conformity to MRL and dietary risk assessment, it will be considered the active ingredient clothianidin".

Products Covered: HS Code(s): 1005; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 14 January 2021 | Final date for Comment: 20 February 2021

This Draft resolution incorporates the following changes for the active ingredient C55.2 – OXICLORETO DE COBRE (copper hydroxide) 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 oats, rye, barley, and triticale with MRL and safety security period without restrictions.

Products Covered: HS Code(s): 1002, 1003, 1004, triticale; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 14 January 2021 | Final date for Comment: 20 February 2021

This Draft resolution incorporates the following changes for the active ingredient C10 – CIPERMETRINA (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 caupi bean, lima bean, chickpea, and lentil cultures with MRL of 0.05 mg/kg and safety security period of 14 days;- includes the phrase: "o) Acute Reference Dose (ARfD): 0.2 mg/kg b.w. (source: EFSA*, 2005);- includes the phrase: "*European Food Safety Authority".

Products Covered: HS Code(s): 071320, 071340, 07133500, 07133990; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 14 January 2021 | Final date for Comment: 20 February 2021

This Draft resolution incorporates the following changes for the active ingredient T33 – TEFLUBENZUROM (teflubenzuron) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application):- changes the MRL from 0.03 to 0.15 mg/kg and the safety security period from 14 to 7 days for the red pepper, egg-plant, scarlet eggplant, okra, and pepper cultures; - includes the phrase: "l) Acute Reference Dose (ARfD): not applicable (source: JMPR*, 2016)";- includes the phrase: "*The Joint FAO/WHO Meeting on Pesticide Residues";- includes the phrase: "m) for the purpose of residue definition for conformity to MRL and dietary risk assessment, it will be considered the active ingredient teflubenzuron".

Products Covered: HS Code(s): 0904, 070930, 07099990, scarlet eggplant; ICS Code(s): 13, 65

Regulation Type: Regular notification