Regulatory Updates
Draft Mexican Official Standard PROY-NOM-244-SSA1-2016 on assessing the bacteria-reducing efficiency of equipment and germicides for domestic water treatment. Sanitary requirements
Distribution date: 28 January 2021
Please be advised that a reply has been published to the comments received on draft Mexican Official Standard PROY-NOM-244-SSA1-2016 on assessing the bacteria-reducing efficiency of equipment and germicides for domestic water treatment. Sanitary requirements, published on 22 October 2018. __________
Products Covered: Equipment and/or germicides for domestic water treatment; national subheadings concerned: 842121 and 380894
Regulation Type: Addendum to Regular Notification
Ortho Phosphoric Acid (Quality Control) Order, 2021
Distribution date: 28 January 2021 | Final date for Comment: 29 March 2021
Ortho Phosphoric Acid is largely used for cleaning sheet metal before painting to retard corrosion and prevent formation rust. It is also used in the manufacture of phosphate salts, polyphosphates, detergents, as a laboratory reagent and in the manufacture of phosphatic fertilizers. So, for protection of human health the standard needs to be made mandatory. The locally manufactured or imported Ortho Phosphoric Acid shall conform to the Indian standard (IS 798: 2020) and shall bear the standard mark under license from the Bureau of Indian Standards (BIS). The use of the standard mark is governed by the provisions of Bureau of Indian Standards Act 2016 and the Rules and Regulations made there under. Bureau of Indian Standards shall be the certifying and enforcing authority.
Products Covered: Ortho Phosphoric Acid (HS Code 2809 2010)
Regulation Type: Regular notification
Ban on certain products containing mercury
Distribution date: 28 January 2021
Please be advised that Secretariat for the Environment and Sustainable Development Resolution (SAyDS) No. 443/2020 updates the guidelines for the definitive or temporary importation of the primary cells and batteries identified in Article 3 and of the appliances or articles containing such items either internally or externally, in accordance with Article 6 of Law No. 26.184. Accordingly, Article 1 of the notified Resolution repeals the regulatory resolutions of Law No. 26.184 notified in documents G/TBT/N/ARG/208 and Add. 1-3 thereto. The aforementioned Law remains in effect. The above does not apply to SAyDS Resolution No. 75/2019 (G/TBT/N/ARG/356) implementing Law No. 27.356 approving the Minamata Convention on Mercury. Punto Focal OTC-OMC de la República Argentina (TBT-WTO Focal Point of the Argentine Republic) Avda. Julio A. Roca 651 Piso 4° Sector 23A (C1067ABB) Ciudad Autónoma de Buenos Aires, Argentina Email: [email protected] __________
Products Covered: Alkali or alkaline-earth metals; rare-earth metals, scandium and yttrium, whether or not intermixed or interalloyed; mercury (HS code(s): 2805); Products of the chemical industry (ICS code(s): 71.100)
Regulation Type: Addendum to Regular Notification
Ban on certain products containing mercury
Distribution date: 28 January 2021
Please be advised that the draft Resolution on the technical quality and safety requirements to be met by certain products, whether or not containing added mercury, produced in or imported into the Argentine Republic, which was notified in document G/TBT/N/ARG/356/Add.1, has been withdrawn. The notification in question should therefore be considered null and void. Punto Focal OTC-OMC de la República Argentina (TBT-WTO Focal Point of the Argentine Republic) Avda. Julio A. Roca 651 Piso 4° Sector 23A (C1067ABB) Ciudad Autónoma de Buenos Aires, Argentina Email: [email protected] __________
Products Covered: Alkali or alkaline-earth metals; rare-earth metals, scandium and yttrium, whether or not intermixed or interalloyed; mercury (HS code(s): 2805); Products of the chemical industry (ICS code(s): 71.100)
Regulation Type: Addendum to Regular Notification
Partial amendment to the Ministerial Order for the Standard of Manufacturing Control and Quality Control for Drugs and Quasi-Drugs.
Distribution date: 27 January 2021 | Final date for Comment: 28 March 2021
The Ministerial Order for the Standard of Manufacturing Control and Quality Control for Drugs and Quasi-Drugs will be partially amended to reflect the Good Manufacturing Practice (GMP) Guide of the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme (PIC/S), which is amended in 2018.
Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30); (ICS code(s): 11.120)
Regulation Type: Regular notification
Se adjunta el texto notificado que fuera omitido en la G/TBT/N/ARG/412.
Distribution date: 22 January 2021
Products Covered: Active pharmaceutical ingredients (APIs); (HS: 30)
Regulation Type: Corrigendum to Regular Notification
This corrigendum aims to inform that the Ministry of Agriculture, Livestock and Food Supply - MAPA has published one rectification on the Technical Regulation no. 94, 18 September 2020, setting the identity and minimum quality requirements for whey and acid whey, regarding the indication of physical-chemical standard values and for the indication of numerical powers in the whey RTIQ, as follows: in Table 3, of Annex I, which deals with the physical-chemical parameters of partially demineralized whey powder and demineralized whey powder, for the parameter referring to ash, where it reads: 1.5 to 1.7, must be read: 1.5 to 7. In the Table 4, of Annex II, which deals with microbiological criteria for whey powder which deals with the microbiological criteria for whey powder, for the criteria of viable mesophilic aerobes/gram, where it reads; m=3,0x104; M=1,0x105, must be read m=3,0x104; M=1,0x105
Distribution date: 22 January 2021
Products Covered:
Regulation Type: Corrigendum to Regular Notification
Partial amendment to the Minimum Requirements for Radiopharmaceuticals.
Distribution date: 21 January 2021 | Final date for Comment: 20 February 2021
The Minimum Requirements for Radiopharmaceuticals will be partially amended to add standards for a radiopharmaceutical to be newly approved.
Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30); (ICS code(s): 11.120)
Regulation Type: Regular notification
Ingredientes Farmacéuticos Activos (IFA) - Ranitidina (Active pharmaceutical ingredients (APIs) - Ranitidine) (3 pages, in Spanish) Text available at: http://www.puntofocal.gov.ar/formularios/notific_arg.php https://members.wto.org/crnattachments/2021/TBT/ARG/21_0618_00_s.pdf
Distribution date: 21 January 2021
As a preventive measure, the marketing throughout the national territory of medicinal preparations containing ranitidine as an active pharmaceutical ingredient (API), as a monodrug or in association with other APIs, in its oral pharmaceutical forms, and in all its concentrations and presentations, has been suspended. (DI-2020-9209-APN-ANMAT#MS)
Products Covered: Active pharmaceutical ingredients (APIs); (HS: 30)
Regulation Type: Regular notification
Methylene Chloride and N-Methylpyrrolidone; Regulation of Certain Uses Under TSCA Section 6(a)
Distribution date: 20 January 2021
TITLE: Withdrawal of Proposed Rules; Discontinuing Three Rulemaking Efforts Listed in the Semiannual Regulatory Agenda AGENCY: Environmental Protection Agency (EPA) ACTION: Withdrawal of proposed rules SUMMARY: The Environmental Protection Agency (EPA) is withdrawing the proposed regulatory requirements described in the three proposed rules that are identified in this document. This document summarizes the proposed rules and provides a brief explanation for the Agency's decision not to finalize the proposed actions. DATES: As of 15 January 2021, the proposed rule published on 16 December 2016 (81 FR 91592; FRL-9949-86)(USA/1247); the proposed rule published on 19 January 2017 (82 FR 7432; FRL-9950-08)(USA/1270); and the portion of the proposed rule published on 19 January 2017 (82 FR 7464; FRL-9958-57)(USA/1271) that pertains to n-Methylpyrrolidone (NMP) and methylene chloride in commercial paint and coating removal, are withdrawn. This withdrawal of proposed rules and earlier actions notified under the symbol G/TBT/N/USA/1271 is identified by Docket Number EPA-HQ-OPPT-2016-0231. The Docket Folder is available on Regulations.gov at https://www.regulations.gov/docket?D=EPA-HQ-OPPT-2016-0231 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. G/TBT/N/USA/1270 and subsequent addenda - Trichloroethylene (TCE); Regulation of Use in Vapor Degreasing Under TSCA Section 6(a) G/TBT/N/USA/1247 and subsequent addenda - Trichloroethylene; Regulation of Certain Uses Under TSCA Sec. 6(a)
Products Covered: Methylene chloride and N-Methylpyrrolidone
Regulation Type: Addendum to Regular Notification
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