Distribution date: 18 December 2023 | Final date for Comment: 16 February 2024

This draft Commission Delegated Regulation amends Regulation (EU) No 528/2012 of the European Parliament and of the Council to include nitrogen generated from ambient air as an active substance in Annex I thereto.

Products Covered: Biocidal products

Regulation Type: Regular notification

Distribution date: 18 December 2023 | Final date for Comment: 22 March 2024

The Therapeutic Products Act, which has been in force since 2002, is currently being revised . Topics which are affected:Advanced therapy medicinal products (ATMPs)Digitalisation in the prescription, dispensing and use of therapeut

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30); Generalities. Terminology. Standardization. Documentation (ICS code(s): 01); Natural and applied sciences (ICS code(s): 07); Health care technology (ICS code(s): 11)

Regulation Type: Regular notification

Distribution date: 18 December 2023 | Final date for Comment: 31 January 2024

The Therapeutic Goods Administration (TGA) administers Australia’s national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods in Australia. There are provisions under the Therapeutic Goods

Products Covered: Medicines

Regulation Type: Regular notification

Distribution date: 15 December 2023 | Final date for Comment: 27 February 2025

The Draft resolution number 734, 22 October 2019 - previously notified through G/TBT/N/BRA/929 - which proposes the updating of the Resolution 36, 26 August 2015, which establishes the risk classification, control scheme of notification, registration,

Products Covered: HS Code(s): 3002300, 3822 (In vitro diagnosis products)

Regulation Type: Addendum to Regular Notification

Distribution date: 15 December 2023 | Final date for Comment: 13 February 2024

The Food and Drug Administration (FDA) proposes to revise the list of ingredients prohibited in cosmetic products. Details of the regulated scope are specified in the attached documents.

Products Covered: Cosmetics; ESSENTIAL OILS AND RESINOIDS; PERFUMERY, COSMETIC OR TOILET PREPARATIONS (HS 33)

Regulation Type: Regular notification

Distribution date: 14 December 2023 | Final date for Comment: 27 February 2025

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Kerry, Inc., proposing that the food additive regulations be amended to provide for the safe use of sodium alginate as a stabilizer and thickener in

Products Covered: Peptones and their derivatives; other protein substances and their derivatives, not elsewhere specified or included; hide powder, whether or not chromed. (HS code(s): 3504); Food technology (ICS code(s): 67)

Regulation Type: Regular notification

Distribution date: 14 December 2023 | Final date for Comment: 27 February 2025

The Regulation on the regulation and control of hazardous and similar substances for domestic, industrial and/or public health use has been approved pursuant to Supreme Decree No. 031-2023-SA and will enter into force six months after publication in the O

Products Covered: Sustancias peligrosas y similares de uso doméstico, industrial y/o en salud pública

Regulation Type: Addendum to Regular Notification

Distribution date: 12 December 2023 | Final date for Comment: 10 February 2024

The notified draft Regulations establish the procedure by which the ARCSA grants a period of exclusivity for test data or other undisclosed information on safety and efficacy, which require considerable effort to obtain, for pharmaceutical products contai

Products Covered: Draft Sanitary Technical Regulations to grant exclusivity for test data for pharmaceutical products containing new chemical entities. The notified draft Regulations establish the procedure by which the ARCSA grants a period of exclusivity for test data or

Regulation Type: Regular notification

Distribution date: 12 December 2023 | Final date for Comment: 10 February 2024

This draft East African Standard specifies requirements, sampling and test methods for phosphate rock fertilizers in powder form of biogenic sedimentary origin.Note: This Draft African Standard was also notified under TBT Committee.

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: Regular notification

Distribution date: 12 December 2023 | Final date for Comment: 10 February 2024

This draft East African Standard specifies requirements, sampling and test methods for granulated phosphate rock fertilizers of biogenic sedimentary origin.Note: This Draft African Standard was also notified under TBT committee

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: Regular notification