Regulatory Updates
Resolution – RDC number 462, 26 January 2021
Distribution date: 01 February 2021
The Resolution – RDC number 402, 21 July 2020 – previously notified through G/TBT/N/BRA/1058 – which establishes the temporary opening of entrance and exit points of substances subject to special control, due to the international public health emergency related to the new Coronavirus (SARS-CoV-2), was changed by the Resolution – RDC number 462, 26 January 2021. The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/5963526/RDC_462_2021_.pdf/468d26ef-79d8-4703-adb6-2b594b5458ea
Products Covered: HS Code(s): 2941; 3003; 3004; 3005; 3006 (pharmaceutical products).
Regulation Type: Addendum to Regular Notification
DMS 29-1:2018, Cement - Part 1: Composition, specifications and conformity criteria for common cements
Distribution date: 29 January 2021 | Final date for Comment: 30 March 2021
This Draft Malawi Standard defines and gives the specifications of 27 distinct common cements, 7 sulphate resisting common cements as well as 3 distinct low early strength blast furnace cements and 2 sulphate resisting low early strength blast furnace cements and their constituents. The definition of each cement includes the proportions in which the constituents are to be combined to produce these distinct products in a range of nine strength classes. This standard does not cover the following cements which have been covered in other standards: Very low heat special cement; Supersulphated cement; Calcium aluminate cement and Masonry cement.
Products Covered: Cement - Part 1: Composition, specifications and conformity criteria for common cements
Regulation Type: Regular notification
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: focalotc@produccion.gob.ar __________
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: focalotc@produccion.gob.ar __________
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
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