Regulatory Updates

Distribution date: 12 October 2021

- __________

Products Covered: Pharmaceutical products (HS code(s): 30); Essential oils and resinoids; perfumery, cosmetic or toilet preparations (HS code(s): 33); Insecticides, rodenticides, fungicides, herbicides, anti-sprouting products and plant-growth regulators, disinfectants and similar products, put up in forms or packings for retail sale or as preparations or articles (for example, sulphur-treated bands, wicks and candles, fly-papers). (HS code(s): 3808); Pharmaceutics (ICS code(s): 11.120); Pesticides and other agrochemicals (ICS code(s): 65.100); Cosmetics. Toiletries (ICS code(s): 71.100.70)

Regulation Type: Addendum to Regular Notification

Distribution date: 08 October 2021 | Final date for Comment: 07 November 2021

Amendment of the provisions for Potency test in the “Recombinant Adsorbed Hepatitis B Vaccine (Prepared from Yeast)”. Amendment of the provisions for Final bulk and final product in the “Polyethylene Glycol-treated Human Anti-HBs Immunoglobulin”, and for Test procedures in the “Test for Measuring the Potency of Human Anti-HBs Immunoglobulin”.

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30); (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 08 October 2021

The proposed maximum residue limits (MRLs) for Diazinon notified in G/SPS/N/JPN/711 (dated 17 December 2019) were adopted and published on 23 April 2020.The specified MRLs are available as below:

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 08 October 2021

The proposed maximum residue limits (MRLs) for Bifenthrin notified in G/SPS/N/JPN/706 (dated 17 December 2019) were adopted and published on 23 April 2020.The specified MRLs are available as below:

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 07 October 2021 | Final date for Comment: 22 November 2021

TITLE: Protection of Stratospheric Ozone: Listing of Substitutes Under the Significant New Alternatives Policy Program; Supplemental Proposal AGENCY: Environmental Protection Agency (EPA) ACTION: Supplemental notice of proposed rulemaking SUMMARY: Pursuant to the U.S. Environmental Protection Agency's Significant New Alternatives Policy program, the Agency is proposing, as an additional option, to list for a limited period of time certain substances in the foamblowing sector, extruded polystyrene: Boardstock and billet end-use, as acceptable, subject to narrowed use limits. This proposal supplements the Agency's 12 June 2020, proposal with respect to the proposed listings in the foam-blowing sector, taking into consideration public comments and information received since issuance of the initial proposal. In the 12 June 2020, proposal, EPA proposed to list three foam blowing agent blends as acceptable. In this supplemental proposal, EPA is proposing an additional approach to list these blends as acceptable, subject to narrowed use limits, in the foam blowing sector, extruded polystyrene: Boardstock and billet end-use, from the effective date of a final rule based on this supplemental proposal until 1 January 2023. The Agency is providing an opportunity for public comment on this additional approach for the listings in the foam blowing sector, as well as reopening the public comment period for the proposed listings in the foam blowing sector in the 12 June 2020, proposal. The Agency is not reopening for comment those other portions of the 12 June 2020, proposal which are addressed in a separate final rule issued 6 May 2021. DATES: Comments on this supplemental proposal must be received on or before 22 November 2021. Any party requesting a public hearing must notify the contact listed below under FOR FURTHER INFORMATION CONTACT by 5 p.m. Eastern Daylight Time on 12 October 2021. If a virtual hearing is held, it will take place on or before 21 October 2021 and further information will be provided on EPA's Stratospheric Ozone website at www.epa.gov/snap. This supplemental notice of proposed rulemaking and previous actions notified under the symbol G/TBT/N/USA/1626 are identified by Docket Number EPA-HQ-OAR-2019-0698. The Docket Folder is available on Regulations.gov at https://www.regulations.gov/docket/EPA-HQ-OAR-2019-0698/document and provides access to primary and supporting documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number. WTO Members and their stakeholders are asked to submit comments to the USA TBT Enquiry Point. Comments received by the USA TBT Enquiry Point from WTO Members and their stakeholders will be shared with the regulator and will also be submitted to the Docket on Regulations.gov if received within the comment period.

Products Covered: Chemical substances

Regulation Type: Addendum to Regular Notification

Distribution date: 06 October 2021

Ministry of Agriculture, Livestock and Food Supply - MAPA issued Ordinance No. 401 that opens a 45-day period for public consultation on proposal of the criteria for the accreditation and supervision of public and private entities for research and experimentation with pesticides, as well as the requirements for conducting studies and reports of agronomic efficiency and practicality for the purposes of registration of pesticides and the like   The Ordinance Project is available on MAPA website: https://www.gov.br/agricultura/pt-br/acesso-a-informacao/participacao-social/consultas-publicas/consulta-publica-criterios-para-o-credenciamento-e-fiscalizacao-de-entidades-publicas-e-privadas-para-realizacao-de-pesquisa-e-experimentacao-com-agrotoxicos-bem-como-os-requisitos-para-a-conducao-dos-estudos-e-laudos-de-eficiencia-e-praticabilidade Technically substantiated suggestions should be forwarded through the Normative Act Monitoring System - SISMAN, of the Department of Agricultural Defense - SDA/MAPA, through the link: https://sistemasweb.agricultura.gov.br/solicita/   MAPA Ordinance No. 380, notified as G/TBT/N/BRA/1230, is revoked

Products Covered: HS 38089910 (pesticides)

Regulation Type: Addendum to Regular Notification

Distribution date: 06 October 2021

This resolution disposes about, on an extraordinary and temporary basis, the permission of the use of medicines and biological products used in the treatment and prevention of Covid-19, from the remaining stock of clinical trials conducted or in progress in Brazil, due to the public health emergency resulting from the outbreak of the new coronavirus (SARS-CoV-2).

Products Covered: 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 for 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 subheadings 3006.10.10 to 3006.60.90 (HS code(s): 3006); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 06 October 2021

The Normative Instruction number 81, 16 December 2020 – previously notified through G/TBT/N/BRA/910/Add.1 – which stablishes a list of radiopharmaceuticals to prove the safety and effectiveness., was modified by Resolution – RDC number 567, 29 September 2021.The final text is available only in Portuguese and can be downloaded at:http://antigo.anvisa.gov.br/documents/10181/6332458/RDC_567_2021_.pdf/79681ce5-5a57-40c3-ba88-e4e4b19a4988

Products Covered: HS CODE: 3006 (radiopharmaceuticals)

Regulation Type: Addendum to Regular Notification

Distribution date: 06 October 2021

The notified draft in document G/SPS/N/MAR/55 dated 25 May 2018 has now been adopted by Dahir No. 1.21.67 of 14 July 2021 on phytopharmaceutical products. [Official Journal No. 7008 of 29 July 2021] https://members.wto.org/crnattachments/2021/SPS/MAR/21_6436_00_x.pdf

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 06 October 2021

The Resolution – RDC number 538, 30 August 2021 - previously notified through  G/TBT/N/BRA/1242 - which disposes about the improvement of the control and inspection of anorectic psychotropic substances and provides other measures., was revoked by Resolution - RDC number 565, 29 September 2021. The final text is available only in Portuguese and can be downloaded at:http://antigo.anvisa.gov.br/documents/10181/6319506/RDC_565_2021_.pdf/5999b0e7-bed0-403c-8edd-50db0ffb3fd9

Products Covered:

Regulation Type: Addendum to Regular Notification