Distribution date: 16 November 2020 | Final date for Comment: 15 January 2021

Red Phosphorus is a versatile chemical with many important applications. The minimum purity 98.5% stipulated in the standard is an important technical characteristic to be fulfilled by the importer and the domestic manufacturer. It is a basic chemical required in the manufacture of phosphorus-based intermediates, which are extensively required in the manufacture of finished pesticides. It is also used in the production of fireworks, safety matches and in metallurgical operations. So, for the protection of plant and human health, the standard needs to be made mandatory. The locally manufactured or imported Red Phosphorus shall conform to the Indian standard (IS 2012: 2006, Reaffirmed 2016) 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 1986 and the Rules and Regulations made thereunder. Bureau of Indian Standards shall be the certifying and enforcing authority.

Products Covered: Red Phosphorus (HS Code 28047020)

Regulation Type: Regular notification

Distribution date: 16 November 2020 | Final date for Comment: 15 January 2021

This chemical is an important dye intermediate used in the manufacture of various types of dyestuffs like Azo Dyes, Reactive Dyes etc. The minimum purity 98% ad crystallization points 69.5 degrees Celsius mentioned in the standard are the important technical characteristics to be met by the exporting entity and the domestic manufacturer.If the intermediates do not meet technical characteristics stipulated in the BIS standards, the impurities of dye-intermediates may enter human chain through textiles thereby impacting the health of the human being. So, it is of paramount importance that dye-intermediates need to conform to BIS standards.So, for the protection of human health, the standard needs to be made mandatory. The locally manufactured or imported 3 (N, N Di-Ethyl) Aminophenol  shall conform to the Indian standard (IS 7686:2020) 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 the Bureau of Indian Standards Act 2016 and the Rules and Regulations made thereunder. Bureau of Indian Standards shall be the certifying and enforcing authority.

Products Covered: 3 (N, N Di-Ethyl) Aminophenol (HS Code 29222914)

Regulation Type: Regular notification

Distribution date: 16 November 2020 | Final date for Comment: 15 January 2021

This chemical is an important dye intermediate used in the manufacture of various types of dyestuffs like Azo Dyes, Reactive Dyes etc. The minimum purity 98% ad crystallization points 69.5 degrees Celsius mentioned in the standard are the important technical characteristics to be met by the exporting entity and the domestic manufacturer.If the intermediates do not meet technical characteristics stipulated in the BIS standards, the impurities of dye-intermediates may enter human chain through textiles thereby impacting the health of the human being. So, it is of paramount importance that dye-intermediates need to conform to BIS standards.So, for the protection of human health, the standard needs to be made mandatory. The locally manufactured or imported 3 (N, N Di-Ethyl) Aminophenol  shall conform to the Indian standard (IS 7686:2020) 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 the Bureau of Indian Standards Act 2016 and the Rules and Regulations made thereunder. Bureau of Indian Standards shall be the certifying and enforcing authority.

Products Covered: 3 (N, N Di-Ethyl) Aminophenol (HS Code 29222914)

Regulation Type: Regular notification

Distribution date: 16 November 2020 | Final date for Comment: 15 January 2021

Methylene Chloride (Dichloromethane) finds application in the manufacturing of Pharmaceuticals, agro chemicals, photographic films etc. Monitoring of purity 99.5% and Heavy Metal content max one PPM warrants making the standard mandatory.Since this item goes to Pharma sector, its quality need to conform to the BIS standards otherwise impurities of Methylene Chloride may enter the animal & human chain. So, for protection of human health, the standard needs to be made mandatory. The locally manufactured or imported Methylene Chloride (Dichloromethane) shall conform to the Indian standard (IS 4566:2020) and shall bear the standard mark under license from the Bureau of Indian Standards (BIS). The use of standard mark is governed by the provisions of Bureau of Indian Standards Act 1986 and the Rules and Regulations made there under. Bureau of Indian Standards shall be the certifying and enforcing authority.

Products Covered: Methylene Chloride (Dichloromethane) (HS Code 29031200)

Regulation Type: Regular notification

Distribution date: 16 November 2020 | Final date for Comment: 15 January 2021

Methylene Chloride (Dichloromethane) finds application in the manufacturing of Pharmaceuticals, agro chemicals, photographic films etc. Monitoring of purity 99.5% and Heavy Metal content max one PPM warrants making the standard mandatory.Since this item goes to Pharma sector, its quality need to conform to the BIS standards otherwise impurities of Methylene Chloride may enter the animal & human chain. So, for protection of human health, the standard needs to be made mandatory. The locally manufactured or imported Methylene Chloride (Dichloromethane) shall conform to the Indian standard (IS 4566:2020) and shall bear the standard mark under license from the Bureau of Indian Standards (BIS). The use of standard mark is governed by the provisions of Bureau of Indian Standards Act 1986 and the Rules and Regulations made there under. Bureau of Indian Standards shall be the certifying and enforcing authority.

Products Covered: Methylene Chloride (Dichloromethane) (HS Code 29031200)

Regulation Type: Regular notification

Distribution date: 16 November 2020 | Final date for Comment: 16 May 2025

The Draft Resolution number 883, 23 July 2020 - previously notified through G/SPS/N/BRA/1745 - was adopted as Resolution - RE number 4447, 29 October 2020. The full text is available only in Portuguese and can be downloaded at:https://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=03/11/2020&jornal=515&pagina=556

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 16 November 2020 | Final date for Comment: 16 May 2025

The Draft Resolution number 883, 23 July 2020 - previously notified through G/SPS/N/BRA/1745 - was adopted as Resolution - RE number 4447, 29 October 2020. The full text is available only in Portuguese and can be downloaded at:https://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=03/11/2020&jornal=515&pagina=556

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 17 November 2020 | Final date for Comment: 16 January 2021

Ministry of Food and Drug Safety of Republic of Korea is proposing to amend the “Standards of In-Vitro Diagnostic Medical Devices Good Manufacturing Practices”. The main changes proposed are: For IVD GMP audits that are subject to documentation review only, there are two additional documents that are required to be submitted.

Products Covered: In-Vitro Diagnostic Medical Devices

Regulation Type: Regular notification

Distribution date: 17 November 2020 | Final date for Comment: 16 January 2021

Ministry of Food and Drug Safety of Republic of Korea is proposing to amend the “Standards of In-Vitro Diagnostic Medical Devices Good Manufacturing Practices”. The main changes proposed are: For IVD GMP audits that are subject to documentation review only, there are two additional documents that are required to be submitted.

Products Covered: In-Vitro Diagnostic Medical Devices

Regulation Type: Regular notification

Distribution date: 17 November 2020 | Final date for Comment: 16 May 2025

The Resolution - RDC number 428, 7 October 2020 - previously notified through G/SPS/N/BRA/1788 - which changes the Resolution - RDC number 177, 21 September 2017, which provides for the ban on the active ingredient Paraquat in pesticides in the country and for transitional risk mitigation measures; and regulates the application of the stocks of the active ingredient Paraquat based products under possession of the Brazilian farmers in the crops management of the agricultural harvest of 2020/2021, was changed by the Resolution - RDC number 436, 5 November 2020. This regulation will be also notified to the TBT committee.The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/6053710/RDC_436_2020_.pdf/b36028dd-b15a-4f6a-97d9-4b90a337cdac

Products Covered:

Regulation Type: Addendum to Regular Notification