Distribution date: 06 May 2024 | Final date for Comment: 22 April 2025

Draft resolution number 1135, 23 December 2022 - previously notified through  G/TBT/N/BRA/1468  - which is regarded to a regulatory proposal for the establishment of specific criteria and procedures for defining the Equivalent Foreign Regulatory Authorities of the sanitary inspection process of manufacturers of active pharmaceutical ingredients, Cannabis products for medicinal purposes, medicines and biological products, was adopted as Normative Instruction 292, 02 May 2024  The final text is available only in Portuguese and can be downloaded at:  https://antigo.anvisa.gov.br/documents/10181/6531690/IN_292_2024_.pdf/33b87ce6-cb6b-4136-b7e8-9adc4d54285d 

Products Covered: Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification

Distribution date: 06 May 2024 | Final date for Comment: 22 April 2025

National Agency for Petroleum, Natural Gas and Biofuels – ANP issued Resolution Nº 968, 30 April 2024, that establishes the specifications of diesel oils intended for vehicles or equipment equipped with Diesel cycle engines and the obligations regarding quality control to be met by economic agents that sell the product in Brazilian territory.The following Resolutions and Resolutions items and articles are revoked: I - ANP Resolution No. 50, 31 December 2013; II - ANP Resolution No. 13, 6 March 2015; III - item IV of the caput of art. 37 and art. 46 of ANP Resolution No. 828, 1 September 2020; IV - art. 30 of ANP Resolution No. 859, 6 December 2021; V - art. 12 of ANP Resolution No. 909, 18 November 2022;  VI - the sole paragraph of art. 1st of ANP Resolution No. 920, 4 April 2023, previously notified through G/TBT/N/BRA/1481.

Products Covered: Biodiesel and mixtures thereof, not containing or containing < 70 % by weight of petroleum oils or oils obtained from bituminous minerals (HS code(s): 3826)

Regulation Type: Addendum to Regular Notification

Distribution date: 14 May 2024 | Final date for Comment: 22 April 2025

Resolution 621, 09 March 2022 - previously notified through G/TBT/N/BRA/1376 - which contains provisions on petitions for license requests, license renewals, post-qualification modifications, testing outsourcing, suspensions and cancellations of Pharmaceutical Equivalence Centers, was changed by Resolution 856, 03 May 204      

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Addendum to Regular Notification

Distribution date: 14 May 2024 | Final date for Comment: 22 April 2025

Resolution 620, 09 March 2022 - previously notified through  G/TBT/N/BRA/1324 - which contains provisions on the Certification of Good Practices for conducting Bioavailability/Bioequivalence studies of medicaments and defines which Bioavailability/Bioequivalence studies of medicines must be carried out in certified research centers, was changed by Resolution 858, 06 May 2024.   

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Addendum to Regular Notification

Distribution date: 14 May 2024 | Final date for Comment: 28 July 2024

This Draft Resolution contains provisions on Inspection Guide for Bioavailability/Bioequivalence Centers for Medicines.

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)

Regulation Type: Regular notification

Distribution date: 14 May 2024 | Final date for Comment: 13 July 2024

This document specifies the basic requirements for the acceptance and hazard classification of explosives, desensitized explosives, and liquid propellants, including acceptance procedures, classification procedures, determination of compatibility groups, requirement of compatibility, and classification test items.This document applies to the hazard assessment of various substances or their products (excluding missiles and nuclear weapons) with deflagrating or explosive characteristics.

Products Covered: explosives, desensitized explosives, liquid propellant (HS code(s): 3601; 3602); (ICS code(s): 13.300; 71.100.30)

Regulation Type: Regular notification

Distribution date: 16 May 2024 | Final date for Comment: 15 July 2024

The Ministry of Health published a new draft of regulations titled "Protection of Public Health Regulations (Food) (Import of dietary supplements by a Proper Importer) 5783-2024. The current import regime includes obtaining prior approval for importing dietary supplements, including importing raw materials, and performing a release procedure after inspection at the quarantine station.A registered importer with a valid importer's certificate will be able to register as a Proper Importer of dietary supplements and meet new threshold conditions as specified in the draft of the new regulations, after which he will be able to obtain prior approval to import nutritional supplements. This approval will significantly reduce the waiting time for receiving the import approvals and the release of the products for marketing from the quarantine stations.These proposed regulations require importers of dietary supplements to be thoroughly familiar with the food legislation and the requirements applicable to the product, to implement a safety system based on risk management, and to be responsible for the safety and quality of the imported dietary supplements and to benefit a simplified and quick preliminary import approval.These proposed regulations will enter into force 12 months after publication in Israel's Official Gazette.Nevertheless, for importers that are already registered as Proper Importer the proposed regulations will enter into force on date of publication.

Products Covered: Dietary supplements (HS code(s): 3004); (ICS code(s): 11.120.10; 67.040)

Regulation Type: Regular notification

Distribution date: 21 May 2024 | Final date for Comment: 22 April 2025

OSHA is amending the Hazard Communication Standard (HCS) to conform to the United Nations' Globally Harmonized System of Classification and Labelling of Chemicals (GHS), primarily Revision 7 (Rev. 7), address issues that arose during the implementation of the 2012 update to the HCS, and provide better alignment with other U.S. agencies and international trading partners, while enhancing the effectiveness of the standard. Consistent with Executive Order 13563 and the Regulatory Flexibility Act, which call for assessment and, where appropriate, modification and improvement of existing rules, OSHA has reviewed the existing HCS. The agency has determined that the revisions in this final rule will enhance the effectiveness of the HCS by ensuring employees are appropriately apprised of the chemical hazards to which they may be exposed, thus reducing the incidence of chemical-related occupational illnesses and injuries. The modifications to the standard include revised criteria for classification of certain health and physical hazards, revised provisions for updating labels, new labeling provisions for small containers, new provisions related to trade secrets, technical amendments related to the contents of safety data sheets (SDSs), and related revisions to definitions of terms used in the standard. This final rule is effective 19 July 2024. The incorporation by reference of certain publications listed in this final rule is approved by the Director of the Federal Register as of 19 July 2024. The incorporation by reference of certain other publications listed in the rule was approved by the Director as of 15 July 2019. Title 29 Code of Federal Regulations (CFR) Part 1910 This final rule and previous actions notified under the symbol G/TBT/N/USA/1697 are identified by Docket Number OSHA-2019-0001. The Docket Folder is available on Regulations.gov at https://www.regulations.gov/docket/OSHA-2019-0001/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.

Products Covered: Chemicals

Regulation Type: Addendum to Regular Notification

Distribution date: 22 May 2024 | Final date for Comment: 21 July 2024

Revision of the Mandatory Standards SI 682 parts 3 and 4, dealing with cribs, to be replaced with SI 11130. This proposed standard revision adopts the European Standard EN 1130:2019/AC: December 2020, with a few changes that appear in the standard's Hebrew section.  The major differences between the old version and this new revised draft standard are as follows:Combines SI 682 parts 3 and 4 into one new standard;Changed the standard's structure to include a new risk-based approach;Adds and updates the test methods;Adds new requirements and test methods for hanging and attaching cribs;Adds new requirements regarding the chemical and thermal risk factors;Adds a rationale in Annex A.Both the old and the new revised standards will apply from entry into force of this revision for a transition period of 6 months. During this time, products may be tested according to the old or the new revised standard. 

Products Covered: Cribs (HS code(s): 9403); (ICS code(s): 97.140; 97.190)

Regulation Type: Regular notification

Distribution date: 22 May 2024 | Final date for Comment: 22 April 2025

Draft Resolution 890, 24 July 2020 - previously notified through G/TBT/N/BRA/1057 - which establishes the lists of medicinal gases subject to notification, was adopted as Resolution 870, 17 May 2024. The final text is available only in Portuguese and can be downloaded at:  https://antigo.anvisa.gov.br/documents/10181/3428523/RDC_870_2024_.pdf/f56f27f3-87be-43c0-ac3d-6393ffa4735a 

Products Covered: Medicaments (excluding goods of heading No. 3002, 3005 or 3006) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or informs or packings for retail sale. (HS code(s): 3003); Medicaments (excluding goods of heading No. 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale. (HS code(s): 3004); Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes. (HS code(s): 3005); Pharmaceutical goods specified in Note 3 to this Chapter. (HS code(s): 3006); Anaesthetic, respiratory and reanimation equipment (ICS code(s): 11.040.10)

Regulation Type: Addendum to Regular Notification