Regulatory Updates
DMS 374-3:2021, Plastics piping systems — Polyethylene (PE) pipes and fittings for water supply — Part 3: Fittings
Distribution date: 17 March 2022 | Final date for Comment: 16 May 2022
This document specifies the fittings made from polyethylene (PE) for buried or above ground applications, intended for the conveyance of water for human consumption, raw water prior to treatment, drainage and sewerage under pressure, vacuum sewer systems, and water for other purposes.
Products Covered: This document also specifies the test parameters for the test methods referred to in this document. In conjunction with the other parts of the DMS 374 series, this document is applicable to PE fittings, to joints with components of PE or other materials, intended to be used under the following conditions
Regulation Type: Regular notification
DMS 374-2:2021, Plastics piping systems — Polyethylene (PE) pipes and fittings for water supply — Part 2: Pipes
Distribution date: 17 March 2022 | Final date for Comment: 16 May 2022
This document specifies the pipes made from polyethylene (PE) for buried or above ground applications, intended for the conveyance of: water for human consumption; raw water prior to treatment; drainage and sewerage under pressure; vacuum sewer systems; and water for other purposes.
Products Covered: This document specifies the pipes made from polyethylene (PE) for buried or above ground applications, intended for the conveyance of, water for human consumption; raw water prior to treatment; drainage and sewerage under pressure; vacuum sewer systems; and water for other purposes.
Regulation Type: Regular notification
Resolution number 606, 23 February 2022
Distribution date: 15 March 2022
This resolution defines the extraordinary and temporary criteria and procedures for the certification of good manufacturing practices for the purpose of market authorization and post-market authorization changes of active pharmaceutical ingredient, medicine and health products due to the international public health emergency of the new Coronavirus. The Foreign Regulatory Authorities, for the purposes of the actions described in the caput, are those members of: I - PIC/S (Pharmaceutical Inspection Cooperation Scheme/Scheme for Cooperation in Pharmaceutical Inspection) for certifications related to medicines and pharmaceutical ingredients; II - MDSAP (Medical Device Single Audit Program) for certifications related to medical devices; or III - Programme to rationalize international GMP inspections of active pharmaceutical ingredients/active substance manufacturers for certifications related to pharmaceutical ingredients.
Products Covered: Active Pharmaceutical Ingredients (HS 3006)
Regulation Type: Regular notification
Regulation on the storage & Transportation of Biological products
Distribution date: 15 March 2022 | Final date for Comment: 14 May 2022
Pursuant to the amendment (July 16, Ordinance of the Prime Minister No. 1717) of The Rules on the Manufacturing and Sales management of biological products, etc, the regulation concerned is to determine the matters delegated in accordance with the Prime Minister Ordinance in relation to the procedures and methods required for storage and transportation, etc. of biological products, etc
Products Covered: Pharmaceuticals
Regulation Type: Regular notification
Normative Instruction number 119, 23 February 2022
Distribution date: 15 March 2022
This resolution contains provisions on technical attributes of medical devices selected for economic monitoring by Anvisa.
Products Covered: Medical Devices (HS 3006)
Regulation Type: Regular notification
The Resolution number 600, 09 February 2022 - previously notified through G/TBT/N/BRA/1307- which stablishes the list of allowed ultraviolet filters for personal hygiene products, cosmetics and perfumes and internalizes GMC MERCOSUR Resolution No. 44/2015, amended by GMC MERCOSUR Resolution No. 14/2021, was rectified.
Distribution date: 15 March 2022
Products Covered: HS – 3304, 3303, 3306, 3307 (toiletries, cosmetics and perfumes)
Regulation Type: Corrigendum to Regular Notification
Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards)
Distribution date: 14 March 2022
Proposal of maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Sulfoxaflor.
Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) - Dairy produce and birds' eggs (HS Codes: 04.01, 04.07 and 04.08) - Animal originated products (HS Code: 05.04) - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14) - Edible fruit and nuts, peel of citrus fruit (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Mate and spices (HS Codes: 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) - Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS Codes: 12.01, 12.05, 12.07 and 12.12) - Animal fats and oils (HS Codes: 15.01, 15.02 and 15.06) - Cocoa (HS Code: 18.01)
Regulation Type: Regular notification
Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards)
Distribution date: 14 March 2022 | Final date for Comment: 13 May 2022
Proposal of maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Pyraflufen-ethyl.
Products Covered: - Edible vegetables and certain roots and tubers (HS Codes: 07.01,07.02, 07.03 07.04, 07.05, 07.06, 07.07, 07.08, 07.09 , 07.10, 07.13 and 07.14) - Edible fruit and nuts, peel of citrus fruit (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Tea, mate and spices (HS Codes: 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10,02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) - Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS Codes: 12.01, 12.02, 12.07, 12.10 and 12.12)
Regulation Type: Regular notification
Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards)
Distribution date: 14 March 2022 | Final date for Comment: 13 May 2022
Proposal of maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Pyraflufen-ethyl.
Products Covered: - Edible vegetables and certain roots and tubers (HS Codes: 07.01,07.02, 07.03 07.04, 07.05, 07.06, 07.07, 07.08, 07.09 , 07.10, 07.13 and 07.14) - Edible fruit and nuts, peel of citrus fruit (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Tea, mate and spices (HS Codes: 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10,02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) - Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS Codes: 12.01, 12.02, 12.07, 12.10 and 12.12)
Regulation Type: Regular notification
Motif FoodWorks, Inc.; Filing of Color Additive Petition
Distribution date: 16 February 2022
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Motif FoodWorks, Inc., proposing that the color additive regulations be amended to provide for the safe use of myoglobin as a color additive in meat and poultry analogue products. The color additive petition was filed on 13 December 2021.
Products Covered: HS Code(s): 20, 3203; ICS Code(s): 67
Regulation Type: Regular notification
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