Regulatory Updates

Distribution date: 06 December 2019

Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Chloropicrin.

Products Covered: - 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 fruit (HS Codes: 08.07, 08.08, 08.10 and 08.11) - Mate and spices (HS Codes: 09.03 and 09.10) - Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08)- Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS Codes: 12.01, 12.02 and 12.12)

Regulation Type: Regular notification

Distribution date: 06 December 2019

Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Dichlobentiazox.

Products Covered: Cereals (HS Code: 10.06)

Regulation Type: Regular notification

Distribution date: 05 December 2019 | Final date for Comment: 17 December 2019

The notified draft Regulations provide for major changes in the sanitary register, as they may have repercussions on the quality, safety and effectiveness of pharmaceutical products, and establish the conditions and documents required for such changes.

Products Covered: Pharmaceutical products; Fish, fresh or chilled, excluding fish fillets and other fish meat of heading 03.04 (HS 0302); Glands and other organs for organo-therapeutic uses, dried, whether or not powdered; extracts of glands or other organs or of their secretions for organo-therapeutic uses; heparin and its salts; other human or animal substances prepared for therapeutic or prophylactic uses, not elsewhere specified or included (HS 3001); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale (HS 3003); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale (HS 3004); Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes (HS 3005); Pharmaceutical goods specified in Note 4 to this Chapter (HS 3006)

Regulation Type: Regular notification

Distribution date: 03 December 2019 | Final date for Comment: 23 December 2019

The notified Directive has been issued in response to the need for measures that reduce, prevent or eliminate risks to public health arising from the presence of chemical residues and contaminants in meat products imported into the Plurinational State of Bolivia.

Products Covered: HS codes: 0201, 0202, 0203 and 0206

Regulation Type: Regular notification

Distribution date: 02 December 2019 | Final date for Comment: 03 January 2020

This Draft Resolution establishes criteria for the changing of information of medical devices after its market authorization and provides other measures.

Products Covered: HS Code(s): 2936, 2937, 3001, 3002, 3003, 3004, 3006 (medical devices)

Regulation Type: Regular notification

Distribution date: 02 December 2019

Products Covered: Hydraulic brake fluids and other prepared liquids for hydraulic transmission not containing petroleum oil or bituminous mineral oil, or containing < 70% petroleum oil or bituminous mineral oil by weight (HS code(s): 3819); Hydraulic brake fluids and other prepared liquids for hydraulic transmission not containing petroleum oil or bituminous mineral oil, or containing < 70% petroleum oil or bituminous mineral oil by weight (HS code(s): 381900); Braking systems (ICS code(s): 43.040.40)

Regulation Type: Addendum to Regular Notification

Distribution date: 02 December 2019

Products Covered: Medicines

Regulation Type: Addendum to Regular Notification

Distribution date: 02 December 2019 | Final date for Comment: 03 January 2020

This Draft Normative Instruction establishes the topics for the changing of information presented in the process of market authorization of medical devices in ANVISA.

Products Covered: HS Code(s): 2936, 2937, 3001, 3002, 3003, 3004, 3006 (medical devices)

Regulation Type: Regular notification

Distribution date: 02 December 2019 | Final date for Comment: 03 January 2020

This Draft Normative Instruction establishes the final date for the beginning of transmission of data and definition for the implantation of the National Medicine Control System (NMCS).

Products Covered: HS Code(s): 30 (medicines, pharmaceutical prodducts)

Regulation Type: Regular notification

Distribution date: 02 December 2019

Products Covered: Paints and varnishes, incl. enamels and lacquers, based on synthetic polymers or chemically modified natural polymers, dispersed or dissolved in a non-aqueous medium; solutions of products of subheading 3901 to 3913 in volatile organic solvents, containing > 50% solvent by weight (excl. solutions of collodion) (HS code(s): 3208); Paints and varnishes, incl. enamels and lacquers, based on polyesters, dispersed or dissolved in a non-aqueous medium; solutions based on polyesters in volatile organic solvents, containing > 50% solvent by weight (HS code(s): 320810); Paints and varnishes, incl. enamels and lacquers, based on acrylic or vinyl polymers, dispersed or dissolved in a non-aqueous medium; solutions based on acrylic or vinyl polymers in volatile organic solvents, containing > 50% solvent by weight (HS code(s): 320820); Paints and varnishes based, incl. enamels and lacquers, on synthetic polymers or chemically modified natural polymers, dispersed or dissolved in a non-aqueous medium, and solutions of products of subheading 3901 to 3913 in volatile organic solvents, containing > 50% solvent by weight (excl. those based on polyesters and acrylic or vinyl polymers and solutions of collodion) (HS code(s): 320890); Paints and varnishes, incl. enamels and lacquers, based on synthetic polymers or chemically modified natural polymers, dispersed or dissolved in an aqueous medium (HS code(s): 3209); Paints and varnishes, incl. enamels and lacquers, based on acrylic or vinyl polymers, dispersed or dissolved in an aqueous medium (HS code(s): 320910); Paints and varnishes, incl. enamels and lacquers, based on synthetic or chemically modified natural polymers, dispersed or dissolved in an aqueous medium (excl. those based on acrylic or vinyl polymers) (HS code(s): 320990); Paints and varnishes, incl. enamels, lacquers and distempers (excl. those based on synthetic polymers or chemically modified natural polymers); prepared water pigments of a kind used for finishing leather (HS code(s): 3210); Paints and varnishes, incl. enamels, lacquers and distempers (excl. those based on synthetic polymers or chemically modified natural polymers); prepared water pigments of a kind used for finishing leather (HS code(s): 321000); Pigments, incl. metallic powders and flakes, dispersed in non-aqueous media, in liquid or paste form, of a kind used in the manufacture of paints; colorants and other colouring matter, n.e.s. put up for retail sale (HS code(s): 321290); Sets of artist's, student's or signboard painter's colours, modifying tints, amusement colours and the like, in tablets, tubes, jars, bottles, pans or similar packages (HS code(s): 321310); Glaziers' putty, grafting putty, resin cements, caulking compounds and other mastics; painters' fillings (HS code(s): 321410); Saturated polyesters in primary forms (excl. polycarbonates, alkyd resins and poly"ethylene terephthalate") (HS code(s): 390799); Paints and varnishes (ICS code(s): 87.040)

Regulation Type: Addendum to Regular Notification