Regulatory Updates

Distribution date: 18 July 2025 | Final date for Comment: 16 September 2025

 1.1  This draft African standard specifies requirements, sampling and test methods for adhesive plaster (also known as adhesive tape) for medical use.

Products Covered: Adhesive dressings and other articles having an adhesive layer, impregnated or covered with pharmaceutical substances or put up for retail sale for medical, surgical, dental or veterinary purposes (HS code(s): 300510)

Regulation Type: Regular notification

Distribution date: 18 July 2025 | Final date for Comment: 16 September 2025

  1.1         This Draft African Standard  specifies the requirements, sampling and test methods for non-absorbable surgical sutures and surgical ligatures.  1.2       This standard does not cover antimicrobial impregnated non -absorbable sutures.                                              

Products Covered: Sterile surgical catgut, similar sterile suture materials and sterile tissue adhesives for surgical wound closure; sterile laminaria and sterile laminaria tents; sterile absorbable surgical or dental haemostatics (HS code(s): 300610)

Regulation Type: Regular notification

Distribution date: 18 July 2025

The purpose of this Notice of Intent is to announce that Health Canada will add a new part “g” to the qualifier of the “Nicotine or its salts” listing on the human use part of the Prescription Drug List (PDL). The new part will provide for the non-prescription status of some orally disintegrating or sublingual nicotine tablets. Orally disintegrating or sublingual tablets that contain 4 mg or less of nicotine per dosage unit were assessed against a set of established and publicly available criteria outlined in section C.01.040.3 of the Food and Drug Regulations (FDR). From this assessment, it was determined that none of the criteria applied and therefore the tablets should have non-prescription status. The wording of the qualifier has changed from that proposed in the 13 February 2025 Notice of Consultation, notified under G/TBT/N/CAN/742. The revised wording is as follows: “in the form of an orally disintegrating or sublingual tablet containing 4 milligrams or less of nicotine per dosage unit for buccal absorption”. This amendment will be in effect on 21 July 2025 and will be communicated through the posting of a Notice of Amendment on the Health Canada website.

Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)

Regulation Type: Addendum to Regular Notification

Distribution date: 18 July 2025

The purpose of this notice of intent is to announce that Health Canada will revise the qualifier of the “Nicotine or its salts” listing on the human use part of the Prescription Drug List (PDL). The intent is to clarify the non-prescription status of nicotine buccal pouches by: amending part "d" of the qualifier of the listing to be specific to sprays and inhalers only and adding a new part "f" to the qualifier that is specific to nicotine buccal pouches. The wording of the qualifier has not changed from that proposed in the 13 February 2025 Notice of Consultation, notified under G/TBT/N/CAN/741. This revision will be in effect six months from the date that the Notice of Intent is posted on the Health Canada website.

Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)

Regulation Type: Addendum to Regular Notification

Distribution date: 18 July 2025 | Final date for Comment: 16 September 2025

  1. 1 This Draft African Standard specifies requirements, sampling and  methods  of test for medical cotton  swab.  1.2 This standard shall not apply to non-woven cotton swabs 

Products Covered: Wadding, gauze, bandages and the like, e.g. dressings, adhesive plasters, poultices, impregnated or covered with pharmaceutical substances or put up for retail sale for medical, surgical, dental or veterinary purposes (HS code(s): 3005)

Regulation Type: Regular notification

Distribution date: 18 July 2025 | Final date for Comment: 16 September 2025

 1.1 This Draft African Standard specifies the requirements, sampling and test methods of zinc oxide surgical adhesive plaster (tape).

Products Covered: Adhesive dressings and other articles having an adhesive layer, impregnated or covered with pharmaceutical substances or put up for retail sale for medical, surgical, dental or veterinary purposes (HS code(s): 300510)

Regulation Type: Regular notification

Distribution date: 18 July 2025 | Final date for Comment: 18 July 2025

Draft Decree detailing the implementation of Law No. 15.022/2024, including the registration, prioritization, risk assessment and risk management of industrial chemicals in Brazil. The goal is to reduce the impacts on human health and the environment generated by the production, import and use of those chemical substances in the country and to define appropriate risk management tools. Note for clarification: this Law will establish the general guidelines for the matter.

Products Covered: HS Chapter 28 – Inorganic chemicals; organic or inorganic compounds of precious metals, of rare-earth metals, of radioactive elements or of isotopes; HS Chapter 29 – Organic chemicals.

Regulation Type: Regular notification

Distribution date: 17 July 2025 | Final date for Comment: 15 September 2025

Proposal of maximum residue limits (MRLs) for the following agricultural chemical:Pesticide: Spinetoram.

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, birds' eggs and natural honey (HS codes: 04.01, 04.07, 04.08 and 04.09)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)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: 10.05 and 10.06)Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.01, 12.07 and 12.12)Animal fats and oils (HS codes: 15.01, 15.02 and 15.06)

Regulation Type: Regular notification

Distribution date: 17 July 2025 | Final date for Comment: 15 September 2025

Proposal of maximum residue limits (MRLs) for the following agricultural chemical:Pesticide: Etofenprox.

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)Aquatic animals and crustaceans, molluscs and other aquatic invertebrates (HS codes: 03.02, 03.03, 03.04, 03.06, 03.07 and 03.08)Dairy produce, birds' eggs and natural honey (HS codes: 04.01, 04.07, 04.08 and 04.09)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: 08.02, 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, 12.05, 12.07 and 12.12)Animal fats and oils (HS codes: 15.01, 15.02 and 15.06)

Regulation Type: Regular notification

Distribution date: 17 July 2025 | Final date for Comment: 15 September 2025

Proposal of maximum residue limits (MRLs) for the following agricultural chemical:Pesticide: Butachlor.

Products Covered: ・ Aquatic animals and crustaceans, molluscs and other aquatic invertebrates (HS codes: 03.02, 03.03, 03.04, 03.06, 03.07 and 03.08)・ Cereals (HS code: 10.06) 

Regulation Type: Regular notification