Regulatory Updates

Distribution date: 05 August 2025

The Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by the Spoonbill Foundation, proposing that we amend our food additive regulations to provide for the safe use of 4′- phosphopantetheine (4′-PPT) as a nutrient in medical food. The food additive petition was filed on 3 July 2025

Products Covered: Food preparations, n.e.s. (HS code(s): 2106); Waters, incl. mineral waters and aerated waters, containing added sugar or other sweetening matter or flavoured, and other non-alcoholic beverages (excl. fruit, nut or vegetable juices and milk) (HS code(s): 2202); 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); Food technology (ICS code(s): 67)

Regulation Type: Regular notification

Distribution date: 05 August 2025

The Normative Instruction number 162, 01 July 2022 - previously notified through G/TBT/N/BRA/1417 - which establishes the acceptable daily intake (ADI), the acute reference dose (DRfA) and maximum residue limits (MRL) for active pharmaceuticals ingredients (API) of veterinary drugs in foods of animal origin, was changed by Normative Instruction  381, 28 July 2025. The final text is available only in Portuguese and can be downloaded at:  https://anvisalegis.datalegis.net/action/UrlPublicasAction.php?acao=abrirAtoPublico&num_ato=00000381&sgl_tipo=INM&sgl_orgao=DC/ANVISA/MS&vlr_ano=2025&seq_ato=000&cod_modulo=134&cod_menu=1696 

Products Covered: Pharmaceutical goods specified in Note 4 to this Chapter. (HS code(s): 3006)

Regulation Type: Addendum to Regular Notification

Distribution date: 05 August 2025

Resolution - RDC number 730, 01 July 2022 - previously notified through G/TBT/N/BRA/1421 - which contains provisions on human health risk assessment of veterinary medicinal products, maximum residue limits (MRLs) of veterinary medicinal products in foods of animal origin and methods of analysis for conformity assessment purposes, was changed by Resolution 984, 28 July 2025  The final text is available only in Portuguese and can be downloaded at:  https://anvisalegis.datalegis.net/action/UrlPublicasAction.php?acao=abrirAtoPublico&num_ato=00000984&sgl_tipo=RDC&sgl_orgao=RDC/DC/ANVISA/MS&vlr_ano=2025&seq_ato=000&cod_modulo=134&cod_menu=1696 

Products Covered: Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale. (HS code(s): 3003); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale. (HS code(s): 3004)

Regulation Type: Addendum to Regular Notification

Distribution date: 04 August 2025 | Final date for Comment: 27 September 2026

This part of DARS 1567 covers the definitions, basic requirements for packing, labelling, marking of fabrics that are suitable for use in the manufacture of school clothing (uniform). Specific requirements are covered by the relevant parts of ARS 1567.

Products Covered: Synthetic organic colouring matter, whether or not chemically defined; preparations based on synthetic organic colouring matter of a kind used to dye fabrics or produce colorant preparations; synthetic organic products of a kind used as fluorescent brightening agents or as luminophores, whether or not chemically defined (excl. preparations of heading 3207, 3208, 3209, 3210, 3213 and 3215) (HS code(s): 3204); Products of the textile industry (ICS code(s): 59.080)

Regulation Type: Regular notification

Distribution date: 01 August 2025 | Final date for Comment: 30 September 2025

Under the provision of the Poisonous and Deleterious Substances Control Act, Ministry of Health Labour and Welfare designates 1 substance as deleterious.

Products Covered: Deleterious substance

Regulation Type: Regular notification

Distribution date: 30 July 2025 | Final date for Comment: 28 September 2025

The draft Order proposes amendments to the preamble of the Order of the Ministry of Agrarian Policy and Food of Ukraine No. 1450 of 31 July 2023 "On Approval of Requirements for Fruit Juices and Certain Similar Products" (notified in the document G/TBT/N/UKR/146/Rev.1/Add.1) and to the Requirements, by setting them out in a new version that introduces the following updates:- the introduction of a new category of products for fruit juices, namely fruit juice with reduced sugar content, concentrated fruit juice with reduced sugar content and fruit juice from concentrate with reduced sugar content. These products have a reduced level of naturally occurring sugars while maintaining the essential physical, chemical, organoleptic, and nutritional characteristics typical of juice derived from the respective fruits;- the inclusion of sunflower seed protein in the list of permitted processing methods and substances used for clarifying fruit juices and certain similar food products;- the addition of analytical methods to ensure compliance with the compositional characteristics of certain types of fruit juices;- the addition of the term "coconut water" as a synonym for "coconut juice" to the special names for fruit juices and certain similar food products.It is also established that fruit juices and certain similar food products that complied with the requirements in effect prior to the entry into force of this Order, but do not meet the provisions of the updated Requirements, may continue to be produced and/or placed on the market for a period of three years from the date this Order enters into force, and may remain on the market until the end of their consumption date or the expiry of their minimum shelf life.The draft Order has been developed to align national legislation with relevant EU law.It is also notified under the SPS Agreement.

Products Covered: Fruit juice, fruit juice from concentrate, concentrated fruit juice, dehydrated/powdered fruit juice, fruit nectar (HS code(s): 2009)

Regulation Type: Regular notification

Distribution date: 29 July 2025

Burundi, Kenya, Rwanda, Tanzania and Uganda would like to inform WTO Members that the Draft East African Standard; DEAS 1119-5:2023, Skin applied mosquito repellents — Specification — Part 5: Bracelets, wrist bands and patches, First Edition; notified in  G/TBT/N/BDI/412, G/TBT/N/KEN/1517, G/TBT/N/RWA/947, G/TBT/N/TZA/1047 and G/TBT/N/UGA/1862  was adopted by the East African Community Council of Ministers on 2 July 2025.

Products Covered: (HS code(s): 380891); Insecticides (ICS code(s): 65.100.10)

Regulation Type: Addendum to Regular Notification

Distribution date: 29 July 2025

Burundi, Kenya, Rwanda, Tanzania and Uganda would like to inform WTO Members that the Draft East African Standard; DEAS 461-2: 2023, Hair dye — Specification — Part 2: Aryl di-amine-based liquid oxidation, First Edition; notified in  G/TBT/N/BDI/401, G/TBT/N/KEN/1496, G/TBT/N/RWA/925, G/TBT/N/TZA/1029 and G/TBT/N/UGA/1836  was adopted by the East African Community Council of Ministers on 2 July 2025.

Products Covered: Preparations for use on the hair (excl. shampoos, preparations for permanent waving or straightening and hair lacquers) (HS code(s): 330590); Cosmetics. Toiletries (ICS code(s): 71.100.70); Hair dye

Regulation Type: Addendum to Regular Notification

Distribution date: 29 July 2025

Burundi, Kenya, Rwanda, Tanzania and Uganda would like to inform WTO Members that the Draft East African Standard; DEAS 461-1: 2023, Hair dye — Specification — Part 1: Aryl diamine based formulated powder, Third Edition; notified in  G/TBT/N/BDI/399, G/TBT/N/KEN/1494, G/TBT/N/RWA/923, G/TBT/N/TZA/1027 and G/TBT/N/UGA/1834  was adopted by the East African Community Council of Ministers on 2 July 2025.

Products Covered: Preparations for use on the hair (excl. shampoos, preparations for permanent waving or straightening and hair lacquers) (HS code(s): 330590); Cosmetics. Toiletries (ICS code(s): 71.100.70); Hair dye

Regulation Type: Addendum to Regular Notification

Distribution date: 29 July 2025

Burundi, Kenya, Rwanda, Tanzania and Uganda would like to inform WTO Members that the Draft East African Standard; DEAS 1205-2:2024, Skincare special purpose product— Specification — Part 2: Sunscreen, First Edition; notified in  G/TBT/N/BDI/461, G/TBT/N/KEN/1596, G/TBT/N/RWA/1008, G/TBT/N/TZA/1115 and G/TBT/N/UGA/1919  was adopted by the East African Community Council of Ministers on 2 July 2025.

Products Covered: ESSENTIAL OILS AND RESINOIDS; PERFUMERY, COSMETIC OR TOILET PREPARATIONS (HS code(s): 33); Cosmetics. Toiletries (ICS code(s): 71.100.70); Sunscreen

Regulation Type: Addendum to Regular Notification