Distribution date: 13 November 2024 | Final date for Comment: 12 January 2025

This Draft African standard specifies the requirements, sampling and test methods for dried shredded cassava commonly referred to as Abacha for human consumption.

Products Covered: Edible vegetables and certain roots and tubers (HS code(s): 07); Food products in general (ICS code(s): 67.040)

Regulation Type: Regular notification

Distribution date: 13 November 2024 | Final date for Comment: 12 January 2025

the draft Resolution of the Cabinet of Ministers of Ukraine "On Approval of the Procedure for Imports of Medicines into the Territory of Ukraine" has been developed to regulate the procedure for imports of medicines (except for active pharmaceutical ingredients) into Ukraine in order to ensure compliance with legislative requirements concerning the quality, safety, and efficacy of medicines in the process of their circulation.The Procedure outlines key mechanisms for regulating imports, including certification and quality control of imported batches of medicines, release of imported medicines for circulation within Ukraine; and recording data related to the circulation of imported medicine batches in the State Register of Medicines Put into Circulation that are Imported into the Territory of Ukraine.

Products Covered: Medicines

Regulation Type: Regular notification

Distribution date: 13 November 2024 | Final date for Comment: 12 February 2025

The EPA is proposing to revoke the approvals for all chlorpyrifos containing substances.The approvals under the Hazardous Substances and New Organisms Act 1996 for the import and manufacture for release for chlorpyrifos and chlorpyrifos containing substances are proposed to be revoked. It is proposed that there are non-negligible risks to the environment and to human health. These risks cannot be sufficiently mitigated through restrictions, to a point where the benefits would outweigh these risks. The EPA therefore proposes that the approvals should be revoked with a 6 month phase out period from the date of decision. Additional restrictions on the use of chlorpyrifos containing substances are proposed over the period of the restriction. The assessment of risks, benefits and the proposed revocation of the approvals are detailed in the application and staff assessment report.   Similar regulatory action has been undertaken by other regulators internationally, with chlorpyrifos not permitted for use in Canada and the European Union, and significant restriction in Australia. We also note that chlorpyrifos is proposed to be listed for elimination under the Stockholm Convention. 

Products Covered: Pesticides containing the active ingredient chlorpyrifos 

Regulation Type: Regular notification

Distribution date: 14 November 2024 | Final date for Comment: 20 April 2025

The Food and Drug Administration (FDA or we) received objections and requests for a public hearing submitted by the Environmental Defense Fund, Learning Disabilities Association of America, Center for Food Safety, Center for Environmental Health, Center for Science in the Public Interest, Breast Cancer Prevention Partners, Defend our Health, and Alaska Community Action on Toxics on the denial of a food additive petition (FAP 6B4815) requesting that we revoke specified regulations to no longer provide for the food contact use of 28 ortho-phthalates. We are overruling the objections and denying the requests for a public hearing.

Products Covered: ICS Code(s): 67. Food contact substances

Regulation Type: Addendum to Regular Notification

Distribution date: 14 November 2024 | Final date for Comment: 20 April 2025

The Food and Drug Administration (FDA or we) is responding to the objection that we received from the Environmental Defense Fund, Breast Cancer Prevention Partners, Environmental Protection Network, Environmental Working Group, and Healthy Babies Bright Futures on the final rule that amended the food additive regulations to no longer provide for the use of 25 plasticizers that the petition identified as ortho-phthalates because these food additive uses have been permanently abandoned. After reviewing the objection, FDA has concluded that the objection does not provide a basis for modifying FDA’s final rule amending the food additive regulations.DATES: The effective date of 20 May 2022, for the final rule published on 20 May 2022 (87 FR 31080), is confirmed.

Products Covered: Polycarboxylic acids, their anhydrides, halides, peroxides and peroxyacids; their halogenated, sulphonated, nitrated or nitrosated derivatives (HS code(s): 2917); Food technology (ICS code(s): 67)

Regulation Type: Addendum to Regular Notification

Distribution date: 15 November 2024 | Final date for Comment: 14 January 2025

This draft Malawi standard specifies the requirements, methods of sampling and tests for carbon dioxide used for the carbonation of beverages.

Products Covered: (HS code(s): 29); (ICS code(s): 67.160.01)

Regulation Type: Regular notification

Distribution date: 15 November 2024 | Final date for Comment: 14 January 2025

In response to the amendments to the Tariff Codes, and the “Fee-Charging Standards for Lot Release, Reference Materials, and Testing of Foods, Drugs and Cosmetics,” Attachment 1 to Attachment 3 of the "Regulations for the Inspection and Examination of Imported Medical Devices" are proposed to be modified based on the current situation.

Products Covered: Diagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents whether or not on a backing, whether or not put up in the form of kits (excl.those of heading 3006); certified reference materials (HS code(s): 3822)

Regulation Type: Regular notification

Distribution date: 19 November 2024 | Final date for Comment: 18 January 2025

The draft Order has been developed to establish the procedure for issuing or refusing to issue permits for parallel imports of medicines, including amendments, suspension, renewal, cancellation or termination of such permits. It also aims to ensure the control and pharmacovigilance over medicines, including medical immunobiological products, imported into Ukraine for the purposes of parallel imports and in circulation during the term of validity of the parallel import permit. 

Products Covered: Medicines

Regulation Type: Regular notification

Distribution date: 19 November 2024 | Final date for Comment: 19 December 2024

The Minimum Requirements for Biological Products will be amended as follows:The standard for “High dose Influenza HA Vaccine” that is to be newly approved will be added. And regarding the standard for “pH4-Treated Normal Human Immunoglobulin (Subcutaneous injection)”, the section of “Final bulk and final product” will be partially amended. The Public Notice on National Release Testing will be amended as follows:The criterion, fee, and quantity for “High dose Influenza HA Vaccine” that is to be newly approved will be added. And the quantity for “pH4-Treated Normal Human Immunoglobulin (Subcutaneous injection)” will be partially amended. In addition, the criterion, fee, and quantity for “Lyophilized Human Prothrombin Complex Concentrate”, “pH4-Treated Normal Human Immunoglobulin”, and “Polyethylene Glycol Treated Normal Human Immunoglobulin” will be partially amended.

Products Covered: Pharmaceutical products (HS: 30)

Regulation Type: Regular notification

Distribution date: 19 November 2024 | Final date for Comment: 18 January 2025

The draft Resolution of the Cabinet of Ministers of Ukraine "On Approval of the Procedure for State Registration (Reregistration) of Medicines" has been developed to establish a unified mechanism for the state registration (reregistration) of medicines, including finished medicines, immunobiological medicinal products. The draft Resolution proposes to approve a new Procedure for the State Registration (Reregistration) of Medicines, which provides for:- the procedure for the state registration (reregistration) of medicines, including finished medicines, immunobiological medicinal products, and medicinal products under obligations;- the mechanism for amending the registration dossier materials;- the procedure for making decisions on suspension, cancellation and termination of state registration of a medicine and decisions to refuse state registration of a medicine;- the procedure for evaluating periodically updated safety reports on medicines and making appropriate decisions;- the amount of fees for state registration (reregistration) of medicines and the cost of services for the evaluation of registration dossier materials.

Products Covered: Medicines

Regulation Type: Regular notification