Distribution date: 01 October 2019 | Final date for Comment: 30 November 2019

This Provision is drafted to strengthen the supervision and administration of drug manufacturing.

Products Covered: Dried glands and other organs for organo-therapeutic uses, whether or not powdered; extracts of glands or other organs or their secretions, for organo-therapeutic uses; heparin and its salts; other human or animal substances prepared for therapeutic or prophylactic uses, n.e.s. (HS code(s): 3001); Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excl. yeasts) and similar products (HS code(s): 3002); Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003); Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. those in the form of transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3004); Pharmaceutical preparations and products of subheading Nos 3006.10.10 to 3006.60.90 (HS code(s): 3006); Medicaments (ICS code(s): 11.120.10)

Regulation Type: Regular notification

Distribution date: 01 October 2019 | Final date for Comment: 30 November 2019

This regulation is drafted to strengthen the supervision and administration of drug trading, to standardize drug trading activities, and to ensure the quality and safety of drugs.

Products Covered: Dried glands and other organs for organo-therapeutic uses, whether or not powdered; extracts of glands or other organs or their secretions, for organo-therapeutic uses; heparin and its salts; other human or animal substances prepared for therapeutic or prophylactic uses, n.e.s. (HS code(s): 3001); Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excl. yeasts) and similar products (HS code(s): 3002); Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003); Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. those in the form of transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3004); Pharmaceutical preparations and products of subheading Nos 3006.10.10 to 3006.60.90 (HS code(s): 3006); Medicaments (ICS code(s): 11.120.10)

Regulation Type: Regular notification

Distribution date: 01 October 2019 | Final date for Comment: 30 November 2019

This standard specifies the terms and definitions, classification and grade, technical requirements, test methods, labels and information provided by manufacturers of footwear protecting against chemicals. This standard is applicable to shoes and boots that protect feet from chemical damage during operation. 

Products Covered: Footwear protecting against chemicals

Regulation Type: Regular notification

Distribution date: 30 September 2019 | Final date for Comment: 18 November 2019

This draft normative instruction establishes the list of medicines defined by Anvisa as exempt from prescription, in the form of Lists of over-the-counter medicines (OTC) for biological and synthetic or herbal medicines, annexes I and II of this Normative Instruction, respectively, in attendance with the Resolution – RDC number 98, 1 August 2016.

Products Covered: HS Code(s): 3006 (OTC medicines).

Regulation Type: Regular notification

Distribution date: 26 September 2019 | Final date for Comment: 09 December 2019

Proposed changes to the current regulatory requirements  to: 1. Provide for the phasing out of PFAS (perfluoroalkyl and polyfluoroalkyl substances) containing firefighting foam concentrates, including: Legacy fluorotelomer C8 aqueous film forming foams. This includes products containing perfluorooctanoic acid (PFOA)-related compounds that have just been listed as a Persistent Organic Pollutant (POP) in the Stockholm Convention. Modern fluorotelomer C6 Aqueous Film Forming Foam (AFFF). These are not listed as a POP in the Stockholm Convention, however, they were recommended not to be used as alternatives (to C8 foams) by the Conference of the Parties for the Stockholm Convention. 2. Restrict the purpose for which perfluoroalkyl and polyfluoroalkyl substances (PFAS) firefighting foams may be imported or manufactured to importation or manufacture for certain transitional uses 3. Provide for conditions attaching to the importation or manufacture, use, storage and disposal of PFAS firefighting foams, and the use, storage and disposal of PFAS firefighting foam waste products for the purpose of protecting the environment. 4. Set general conditions on the use of fire-fighting chemicals, including requirements relating to labelling, safety data sheets, packaging and disposal.

Products Covered: The products to be phased out are PFAS (perfluoroalkyl and polyfluoroalkyl substances) containing fire fighting foam concentrates.

Regulation Type: Regular notification

Distribution date: 25 September 2019 | Final date for Comment: 18 November 2019

This Draft resolution incorporates the following changes for the active ingredient F68 - FLUXAPIROXADE (Fluxapyroxad) 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, kiwi and pomegranate cultures with MRL of 0.7 mg/kg and safety security period of 7 days;- includes the sweet potato, yacon, beetroot, greater yam, ginger, yams, manioc, arracacha, turnip and radish cultures with MRL of 0.07 mg/kg and safety security period of 7 days;- includes the chickpea, lentil and caupi bean cultures with MRL of 0.03 mg/kg and safety security period of 14 days; - includes the alstroemeria, alyssum, amaryllis, azalea, snapdragon, purple arrowroot, cockscomb, coleus, carnation,dubosia, euonymus, ruscus, gardenia, geranium, gerbera, gladiolus, hydrangea, lantana, lily, lisianthus, daisy, pinus, ptoporium, garden sage, Sedum makinoi, rubber tree, vervain, vincan and zinnia cultures with MRL and safe security period "not determined"; - changes the MRL of the acai, coconut, palm nuts, macadamia nuts, pine nuts and peach palm cultures from 0.1 to 0.3 mg/kg; - changes the MRL of the groundnut and potato cultures from  0.01 to 0.03 mg/kg;- changes the MRL of the carrot culture from  0.02 to 0.07 mg/kg;- changes the MRL of the mango culture from 0.5 to 0.7 mg/kg.

Products Covered: HS Code(s): 06, 0603, 0604, 200820, 071420, 0706, 091010, 071410, 071320, 071340, 08011, 071010, 080450, 081090, 08105000, 08109090, 17029040000, 07143000, 0714900011, 07133500, 08026000, 08029000, 0810909050, 20081920, 120710, acai; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 25 September 2019 | Final date for Comment: 18 November 2019

This Draft resolution incorporates the following changes for the active ingredient P46 – PIRACLOSTROBINA (pyraclostrobin) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers:- includes the soursop, kiwi and pomegranate cultures with MRL of 0.7 mg/kg and safety security period of 7 days in the modality of foliar use (application);- includes the yacon, beetroot, greater yam, yams, arracacha, turnip and radish cultures with MRL of 0.2 mg/kg and safety security period of 7 days in the modality of foliar use (application);- includes the chickpea, lentil and caupi bean cultures with MRL of 0.02 mg/kg and safety security period of 14 days in the modality of foliar use (application); - includes the alstroemeria, alyssum, amaryllis, azalea, snapdragon, purple arrowroot, cockscomb, coleus, carnation,dubosia, euonymus, ruscus, gardenia, geranium, gerbera, gladiolus, hydrangea, lantana, lily, lisianthus, daisy, pinus, ptoporium, garden sage, Sedum makinoi, rubber tree, vervain, vincan and zinnia cultures with MRL and safe security period "not determined" in the modality of foliar use (application); - changes the MRL of the acai, coconut, palm nuts, macadamia nuts pine nuts and peach palm cultures from  0.2 to 0.5 mg/kg in the modality of foliar use (application); - changes the MRL of the cotton culture from 0.2 to 0.5 mg/kg in the modalities of foliar and seed use (application);- changes the MRL of the potato culture from 0.01 to 0.02 mg/kg in the modalities of foliar and planting furrow use (application);- changes the MRL of the beetroot culture from 0.1 to 0.2 mg/kg in the modality of foliar use (application);- changes the MRL from 0.02 to 0.2 mg/kg and the safety security period from 30 to 7 days for the manioc culture in the modality of foliar use (application);- changes the MRL of the mango, cupuacu, guarana and passion fruit cultures from 0.5 to 0.7 mg/kg in the modality of foliar use (application).

Products Covered: HS Code(s): 0706, 071320, 071340, 08011, 120710, 52, 071010, 071410, 080450, 06, 0603, 0604, 081090, 08105000, 08109090, 17029040000, 07143000, 0714900011, 07133500, 08026000, 08028000, 0810909050, 08109090, acai, cupuacu, guarana; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 25 September 2019 | Final date for Comment: 18 November 2019

This Draft resolution incorporates the following changes for the active ingredient E26 - ESPIROMESIFENO (spiromesifen) 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 lettuce, chard, watercress, witloof chicory, chicory, spinach, stevia rebaudiana and rucola cultures with MRL of 15 mg/kg and safety security period of 1 day;- includes the cucumber, pumpkin, zucchini, chayote and maxixe cultures with MRL of 0.6 mg/kg and safety security period of 1 day;- includes the cabbage, broccoli, kale, chinese cabbage, brussels sprouts, and cauliflower with MRL of 0.1 mg/kg and safety security period of 3 days;- includes the mango, avocado, pineapple, papaya and passion fruit cultures with MRL of 0.7 mg/kg and safety security period of 5 days;- includes plants for ornamental purposes: crysanthemun, roses, begonias, poinsettias and orchid cultures with MRL and safe security period of "Non-food use".

Products Covered: HS Code(s): 07051, 07052, 070521, 070970, 0707, 0704, 1214, 070410, 070420, 0804, 080720, 06, 0603, 0604, 12099110, 12119029, 070990, 07099300, 07096090, 0709991000, 07049010, 08109090, rucola, maxixe; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 25 September 2019 | Final date for Comment: 18 November 2019

This Draft resolution incorporates the following changes for the active ingredient A31 – ÁCIDO 4-INDOL-3-ILBUTÍRICO (4-indol-3-ylbutyric acid) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers:- includes the potato, onion, papaya and melon cultures with MRL and safety security period "not determined" in the modality of foliar use (application);- includes the potato culture with MRL and safety security period "not determined" in the modality of soil use (application).

Products Covered: HS Code(s): 071010, 071220, 0807; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 25 September 2019 | Final date for Comment: 18 November 2019

This Draft resolution incorporates the following changes for the active ingredient C48 – CINETINA (kinetin) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers:- includes the potato, onion, papaya and melon cultures with MRL and safety security period "not determined" in the modality of foliar use (application);- includes the potato culture with MRL and safety security period "not determined" in the modality of soil use (application).

Products Covered: HS Code(s): 071010, 071220, 0807; ICS Code(s): 13, 65

Regulation Type: Regular notification