Notifications for Brazil (1991 notifications)

This document corrects the article 6 of the Resolution - RDC number 281, 29 April 2019, previously notified under G/SPS/N/BRA/1507.  The full text of the original regulation is available only in Portuguese and can be downloaded at: http://portal.anvisa.gov.br/documents/10181/5457548/RDC_281_2019_.pdf/36c32ffd-46ba-48e6-93f8-8d43d0f2329f The text of the changed article is available only  in Portuguese and can be downloaded at: http://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?jornal=515&pagina=47&data=18/06/2019.

This draft resolution establishes the MRL for veterinary drugs in food of animal origin.

This draft resolution establishes the procedure for risk assessment of veterinary drugs to human health and the methods for conformity assessment procedures.

This Draft resolution incorporates the following changes the active ingredient Q05.1 - QUIZALOFOPE-P-ETÍLICO of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers all in the modality of post-emergency use (application):  - the rice culture with MRL of 0.3 mg/kg and safety security period of 45 days.

This Draft resolution incorporates the following changes for the active ingredient C58 - ALFA-CIPERMETRINA 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 sweet potatoes, yacon, greater yam, yam and radish cultures with MRL of 0.02 mg/kg and safety securityu period of 14 days; - includes shallot culture with MRL of 0.05 mg/kg and safety security period of 7 days; - includes raspberry, cranberry and purple mumbim cultures with MRL of 1.0 mg/kg and safety security period of 7 days; - includes cupuacu, kiwifruit and pomegranate cultures with MRL of 0.7 mg/kg and safety security period of 7 days; - includes cassava culture with MRL of 0.05 mg/kg and safety security period of 14 days; - includes gherkin culture with MRL of 0.05 mg/kg and safety security period of 7 days; - includes stevia culture with MRL of 0.07 mg/kg and and safety security period of 7 days; - includes melon culture with MRL of 0.02 mg/kg and safety security period of 10 days; - includes palnts for ornamental purposes: crysanthemun and roses cultures with MRL and safety security period  of non-food use.

This Draft resolution incorporates the following changes for the active ingredient F69 – FLUPIRADIFURONE from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality and of foliar use (application):  - includes the oats, rye, barley, wheat and triticale cultures with MRL of 4.0 mg/kg and safety security period of 75 days; - changes the phrase at item "j": "for the purpose of residue definition for conformity with MRL it will be considered the active ingridient flupiradifurone, and for the dietary risk assessment: flupiradifurone and its metabolite BYI 02960-acid, expressed as flupiradifurone".

This Draft resolution incorporates the following changes the active ingredient T33 - TEFLUBENZUROM of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use(application): - includes kiwifruit and pomegranate cultures with MRL of 0.7 mg/kg and safety security period of 7days; - includes raspberry, cranberry and purple mumbim cultures with MRL of 1.0 mg/kg and safety security period of 7 days; - includes carrot, sweet potatoes, yacon, greater yam, yams, cassava and radish cultures with MRL 0.05 mg/kg and safety security period of 14 days; - includes shallot culture with MRL of 0.03 mg/kg and safety security period of 7 days; - includes witloof chicory and stevia cultures with MRL of 0.3 mg/kg and safety security period of 7 days; - includes gherkin culture with MRL of 0.01 mg/kg and safety security period of 7 days; - includes guarana culture with with MRL of 0.2 mg/kg and safety security period of 7 days; - includes nectarine culture with MRL of 0.2 mg/kg and safety security period of 15 days; - includes linseed culture with MRL of 2.0 mg/kg and safety security period of 7 days; - includes plants for ornamental purposes: alstroemeria, alyssum, amaryllis, azalea, snapdragon, purple arrowroot, cockscomb, coleus, carnation, crysanthemun, euonymus, ruscus, gardenia, geranium, gerbera, gladiolus, hydrangea, lantana, lily, lisianthus, daisy, roses, garden sage, Sedum makinoi, vervain, vincan and zinnia cultures with MRL and safe security period for non-food use; - changes MRL of cupuacu culture from 0.2 to 0.7 mg/kg.

Extend for 30 days the comment period.

This Draft resolution includes the active ingredient L06 – Laminarin of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers.

This Draft resolution incorporates the following changes for the active ingredient B26 – BIFENTRINA 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 coconut culture with MRL of 0.05 mg/kg and safety security period of 7 days.

This Draft resolution includes the active ingredient D55 – DINOTEFURAN of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers.

This Draft resolution incorporates the following changes for the active ingredient E19 - ETOFENPROXI 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 passion fruit and papaya culture with MRL of 0.3 mg/kg and safety security period of 1 day; - includes paprika, eggplant, scarlet eggplant, pepper and okra culture with MRL of 0.7 mg/kg and safety security period of 1 day.

This Draft resolution incorporates the following changes for the active ingredient C63 – LAMBDA-CIALOTRINA 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 soya culture from 0.05 to 0.15 mg/kg and mantains the safety security period of 20 days.

This Draft resolution incorporates the following changes for the active ingredient F36 – FLUTRIAFOL (fenpropimorph) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality and use(application) on soil:- changes the MRL from 0.05 from 0.09 mg/kg for the coffee culture and mantains the safety security period of 120 days.

This Resolution provides for the maintenance of the active ingredient acid 2,4-dichlorophenoxyacetic (2,4-D) in pesticide products in Brazil.

This Draft resolution incorporates the following changes for the active ingredient A29 – ACETAMIPRIDO 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 passion fruit culture with MRL of 0.01 mg/kg and safety security period of 28 days;- changes the MRL from 0.5 to 0.7 mg/kg for fruits of the genus Capsicum or of the genus Pimenta, egg-plant, scarlet eggplant, pepper and okra cultures and safety security period from 3 days to 1 day.

The notified document submits to Public Consultation, a draft of Normative Instruction for the establishment of the procedures and conditions for carrying out stability studies for registration or post-registration amendments of biological products for veterinary use.

This Draft resolution incorporates the following changes for the active ingredient P34 – PIRIPROXIFEM from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers:- includes cane sugar culture with MRL of 0.01 mg/kg and safety security period of 210 days; - includes pasture for "non-food use", therefore there are not definition of LMR nor safety security period.

This Draft resolution includes the active ingredient F72 – FLUOPIRAM of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers.

The draft resolution (Consulta Pública) number 583, 21 December 2018, notifiedf through G/SPS/N/BRA/1465, was adopted as a final text, published as ANVISA Resolution - RDC Nº 285, 17 May 2019. The fulll text is available only in Portuguese and can be downloaded at: http://portal.anvisa.gov.br/documents/10181/5141616/RDC_285_2019_.pdf/ab2c802a-6841-49ff-8266-0c842a5f1fab.