Regulatory Updates
Protection of Stratospheric Ozone: Adjustments to the Allowance System for Controlling HCFC Production and Import, 2020-2029; and Other Updates
Distribution date: 20 March 2020
Final Rule - The U.S. Environmental Protection Agency is allocating production and consumption allowances for specific hydrochlorofluorocarbons, a type of ozone-depleting substance, for the years 2020 through 2029. These hydrochlorofluorocarbons may be used to service certain equipment manufactured before 2020. The EPA is also updating other requirements under the program for controlling production and consumption of ozone-depleting substances, as well as making edits to the regulatory text for improved readability and clarity. These updates include revising the labeling requirements for containers of specific hydrochlorofluorocarbons; prohibiting the transfer of hydrochlorofluorocarbon allowances allocated through this rulemaking into allowances for hydrochlorofluorocarbons that have already been phased out; requiring the use of an electronic reporting system for producers, importers, exporters, transformers, and destroyers of controlled ozone-depleting substances; revising and removing recordkeeping and reporting requirements; improving the process for petitioning to import used ozone-depleting substances for reuse, including by creating more flexibility for imports of used halon from certain halon banks and exempting imports of aircraft bottles containing halon 1211 for hydrostatic testing from the petition process; creating a certification process for importing both used and virgin ozone-depleting substances for destruction; and restricting the sale of known illegally imported substances. This rule includes clarifications to the certification requirements for methyl bromide quarantine and preshipment uses. The EPA is also adding polyurethane foam systems containing ozone-depleting chlorofluorocarbons to the list of nonessential products. Lastly, the Agency is updating the definition of "destruction" as used in the context of the production and consumption phaseout and removing obsolete provisions.
Products Covered: Hydrochlorofluorocarbon production and import
Regulation Type: Regular notification
Revision of the administrative rule of the Official Standards for Fertilizers
Distribution date: 19 March 2020 | Final date for Comment: 18 April 2020
Considering technical advancement and needs for complex fertilizers, the MAFF will revise the administrative rule of the Official standards for fertilizer in order to achieve the progress and sustainability of agricultural productivity and to protect human health. The following agricultural chemicals will be permitted to add a fertilizer as the official standards (Annex 1). (RS)-1-methyl-2-nitro-3-(tetrahydro-3-furylmethyl)guanidine potassium(R)-2-(4-chloro-o-tolyloxy)propionate and 2,6-dichlorobenzonitrile
Products Covered: Fertilizer (HS: 3102, 3103, 3104, 3105)
Regulation Type: Regular notification
The Normative Instruction number 43, 21 August 2019 – previously notified through G/TBT/N/BRA/870/Add.10 – which adopts Complementary guidelines to the manufacture of pressurised metered dose aerosol preparations for inhalation of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) of 1 July 2018, was rectified. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 18 March 2020
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
The Normative Instruction number 39, August 21st, 2019 – previously notified through G/TBT/N/BRA/870/Add.6 – which adopts Complementary guidelines to the manufacture of herbal medicinal products of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) of July 1st, 2018, was republished. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 18 March 2020
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
The Normative Instruction number 38, 21 August 2019 – previously notified through G/TBT/N/BRA/870/Add.5 – which adopts Complementary guidelines to the manufacture of medicinal gases of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) of 1 July 2018, was rectified. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 18 March 2020
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
The Normative Instruction number 35, 21 August 2019 – previously notified through G/TBT/N/BRA/870/Add.2 – which adopts Complementary guidelines to the manufacture of sterile medicinal products of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) of 1 July 2018, was rectified. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 18 March 2020
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
The Draft Resolution 736, 7 November 2019 – previously notified through G/TBT/N/BRA/940 – which establishes the topics for the changing of information presented in the process of market authorization of medical devices in ANVISA, was adopted as Normative Instruction 61, 6 March 2020. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 18 March 2020
Products Covered: HS Code(s): 2936, 2937, 3001, 3002, 3003, 3004, 3006 (medical devices)
Regulation Type: Addendum to Regular Notification
The Normative Instruction number 36, 21 August 2019 – previously notified through G/TBT/N/BRA/870/Add.3 – which adopts Complementary guidelines to the manufacture of biological medicinal substances and products for human use of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) of 1 July 2018, was rectified. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 18 March 2020
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
The Resolution – RDC number 301, 21 August 2019 – previously notified through G/TBT/N/BRA/870/Add.1 – which adopts Good Practice Guidelines for the Manufacture of Medicines of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) of 1 July 2018, was republished. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 18 March 2020
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
The Draft Resolution number 735, 7 November 2019 – previously notified through G/TBT/N/BRA/941 – which establishes criteria for the changing of information of medical devices after its market authorization and provides other measures, was adopted as Resolution – RDC number 340, 6 March 2020. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 18 March 2020
Products Covered: HS Code(s): 2936, 2937, 3001, 3002, 3003, 3004, 3006 (medical devices)
Regulation Type: Addendum to Regular Notification
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