Regulatory Updates

Distribution date: 30 April 2025 | Final date for Comment: 29 June 2025

This Draft East African Standard gives guidelines on how to plan, conduct and evaluate emergency and disaster preparedness tabletops, drill and exercises. This guideline is intended for use by emergency response teams and organizations involved in emergency and disaster management.

Products Covered: First-aid boxes and kits (HS code(s): 300650); First aid (ICS code(s): 11.160)

Regulation Type: Regular notification

Distribution date: 28 April 2025

Ukraine notifies the adoption of the Order of the Ministry of Health of Ukraine No. 277 “Some Issues of Implementation of the Law of Ukraine No. 3860-IX “On Amendments to Certain Laws of Ukraine on Parallel Import of Medicines” of 16 July 2024” of 17 February 2025.The Order was registered in the Ministry of Justice of Ukraine on 19 March 2025 and published on 15 April 2025.The Order entered into force on 15 April 2025. 

Products Covered: Medicines

Regulation Type: Addendum to Regular Notification

Distribution date: 23 April 2025

Products covered: (ICS:91.100.10) Cement. Gypsum. Lime. MortarThis addendum concerns the notification of draft of Egyptian Standard ES 4756-1 "Cement - Part 1: Composition, specifications and conformity criteria for common cements." (partial amendment in 1 page, in Arabic).It should be noted that the Ministerial Decree No. 298 /2023 (1 page, in Arabic) and the Ministerial Decree No.326/2023 (1 page, in Arabic) which were formerly notified in G/TBT/N/EGY/3/Add.60 dated 27 September 2023, the Ministerial Decree No. 189 /2023 (1 page, in Arabic) which was formerly notified in G/TBT/N/EGY/3/Add.57 dated 14 July 2023 and the Ministerial Decree No. 561/2022 (2 pages, in Arabic) which was formerly notified in G/TBT/N/EGY/3/Add.53 dated 20 December 2022, mandated among others the earlier versions of this Egyptian standard.Worth mentioning is that this standard has been partially modified as follows:Table (1) The 27 products in the family of common cements CEMII- Portland – pozzolana cement Main typesNotation of the products(types of common cement)ClinkerBlast- furnace slagSilica fumePozzolanaFly ashBurnt shaleLimestoneMinor additional constituentsnaturalNatural calcined SillceouscalcareouskSDPQVWTLLL CEMIIportland – pozzolana cementCEMII/A-P78-94--6-22------0-5CEMII/B-P65-77--23-35------0-5 Producers and importers are kept informed of any amendments in the Egyptian standards through the publication of administrative orders in the official gazette.Proposed date of adoption: to be determinedProposed date of entry into force: to be determinedAgency or authority designated to handle comments and text available from:National Enquiry PointEgyptian Organization for Standardization and Quality16 Tadreeb El-Modarrebeen St., Ameriya, Cairo - EgyptE-mail: eos@eos.org.eg/ eos.tbt@eos.org.egWebsite: http://www.eos.org.egTel: + (202) 22845528Fax: + (202) 22845504

Products Covered: Chemical, textile and engineering products

Regulation Type: Addendum to Regular Notification

Distribution date: 23 April 2025

This Botswana Standard specifies the physical, chemical and microbiological requirements for bottled natural mineral water for human consumption, bottled at the source. It also specifies permissible treatments and the requirements for bottling and labelling.NOTE The water may be offered as bottled non-carbonated (still) natural mineral water or as bottled carbonated (sparkling) natural mineral water.This standard excludes water that contains sugar, sweeteners, flavourants or other additives.

Products Covered: DRINKING WATER

Regulation Type: Regular notification

Distribution date: 23 April 2025

This Botswana Standard specifies the physical, chemical and microbiological requirements for bottled water other than natural water for human consumption. It also specifies permissible treatments and the requirements for bottling and labelling.NOTE The water may be offered as bottled non-carbonated (still) water or bottled carbonated (sparkling) water.This standard excludes water that contains sugar, sweeteners, flavourants or other additives.

Products Covered: DRINKING WATER

Regulation Type: Regular notification

Distribution date: 23 April 2025

The Draft Resolution number 1253, 06 May 2024 - previously notified through G/TBT/N/BRA/1538 - which contains provisions on Inspection Guide for Bioavailability/Bioequivalence Centers for Medicines., was adopted as Normative Instruction - IN number 358, 14 April 2025. The final text is available only in Portuguese and can be downloaded at: https://pdf.datalegis.net/files/662300f5b7c74d6ebab84b1f29f70eb0.pdf 

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: Addendum to Regular Notification

Distribution date: 15 April 2025

Please be advised of the publication on 19 March 2025 of an AMENDMENT to various points of Mexican Official Standard NOM-059-SSA1-2015: Good manufacturing practices for medicinal products, which was published on 5 February 2016, that will enter into force 180 working days from the day after its publication.__________1 This information can be provided by including a website address, a PDF attachment, or other information on where the text of the final measure/change to the measure/interpretative guidance can be obtained.

Products Covered: Medicaments (HS 30.04) ;

Regulation Type: Addendum to Regular Notification

Distribution date: 14 April 2025

Kenya would like to inform WTO Members that the Draft East African Standard; DEAS 906:2023 Kenya Standard — Fertilizers — Triple superphosphate — Specification, Second Edition, Second Edition, notified in G/TBT/N/BDI/423, G/TBT/N/KEN/1528, G/TBT/N/RWA/958, G/TBT/N/TZA/1058, G/TBT/N/UGA/1873, was adopted and published by Kenya on 20th December 2024 via Gazette Notice No. 16886 dated 20th December 2024 as KS EAS 906:2024 Kenya Standard — Fertilizers — Triple superphosphate — Specification, Second Edition.A copy of the document can be obtained via the following link at a basic fee: https://webstore.kebs.org   

Products Covered: - Superphosphates: (HS code(s): 31031); Fertilizers (ICS code(s): 65.080)

Regulation Type: Addendum to Regular Notification

Distribution date: 14 April 2025

Kenya would like to inform WTO Members that the Draft East African Standard; DEAS 905:2023  Kenya Standard — Fertilizers — Granulated phosphate rock — Specification, Second Edition, notified in G/TBT/N/BDI/422, G/TBT/N/KEN/1527, G/TBT/N/RWA/957, G/TBT/N/TZA/1057, G/TBT/N/UGA/1872, was adopted and published by Kenya on 20th December 2024 via Gazette Notice No. 16886 dated 20th December 2024 as KS EAS 905:2024  Kenya Standard — Fertilizers — Granulated phosphate rock — Specification, Second Edition.A copy of the document can be obtained via the following link at a basic fee: https://webstore.kebs.org

Products Covered: Mineral or chemical phosphatic fertilisers (excl. those in tablets or similar forms, or in packages with a gross weight of <= 10 kg) (HS code(s): 3103); Fertilizers (ICS code(s): 65.080)

Regulation Type: Addendum to Regular Notification

Distribution date: 14 April 2025

Kenya would like to inform WTO Members that the Draft East African Standard; DEAS 904:2023 Kenya Standard — Fertilizers — Phosphate rock powder — Specification, Second Edition, notified in G/TBT/N/BDI/421, G/TBT/N/KEN/1526, G/TBT/N/RWA/956, G/TBT/N/TZA/1056, G/TBT/N/UGA/1871, was adopted and published by Kenya on 20th December 2024 via Gazette Notice No. 16886 dated 20th December 2024 as KS EAS 904:2024 Kenya Standard — Fertilizers — Phosphate rock powder — Specification, Second Edition.A copy of the document can be obtained via the following link at a basic fee: https://webstore.kebs.org  

Products Covered: Mineral or chemical phosphatic fertilisers (excl. those in tablets or similar forms, or in packages with a gross weight of <= 10 kg) (HS code(s): 3103); Fertilizers (ICS code(s): 65.080)

Regulation Type: Addendum to Regular Notification