Assessment of Proposal P1056 – Caffeine review (2nd Call for Submissions)

Distribution date: 06 March 2025 | Final date for Comment: 03 May 2025
This proposal proposes to: - Prohibit the retail sale of a food that is caffeine and prohibit the addition of caffeine to foods for retail sale unless expressly permitted - Expressly permit the addition of caffeine to Formulated supplementary sports foods (FSSF), subject to compositional, packaging and labelling requirements.
Products Covered: Foods for retail sale in Australia and New Zealand in which caffeine has been added, including sports foods.
Regulation Type: Regular notification
Draft Commission Regulation refusing to authorise a health claim made on foods, other than those referring to the reduction of disease risk and to children's development and health

Distribution date: 05 March 2025 | Final date for Comment: 04 May 2025
This draft Commission Regulation concerns the refusal of authorisation of a health claim made on foods, other than those referring to the reduction of disease risk and to children's development and health in accordance with Article 18 of Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods.
Products Covered: Food
Regulation Type: Regular notification
Letter of the Federal Service for Veterinary and Phytosanitary Surveillance No. FS-SA-7/10917 as of 7 April 2020

Distribution date: 05 March 2025
The Russian Federation notifies temporary restrictions on imports of live poultry, poultry products and birds' eggs as well as the transit of live poultry from Heves and Pest regions of Hungary to the territory of the Russian Federation due to deterioration of the epizootic situation with highly pathogenic avian influenza in the regions mentioned.
Products Covered: Live poultry, bird eggs, meat and edible offal of poultry, machinery for preparing animal feeding stuffs, poultry incubators and brooders. HS Codes: 0105; 0407, 0408; 0207;0208,0209,0210,0410 00 000 0,0504 00 000 0,0505,0511,1501,1506 00 000 0,1516 10,1518 00,1601 00,1602, 1603 00,1902 20,1904 20,products from group 20, from 2104, from 2106, 4206 00 000 0, 0106; 508 10 000 0,0106,9705 00 000 0; 9508 10 000 0,0106; 2102, 2309, 2936, 3504, 3507, 3808, 3824; 3923,3926,4415 4416 00 000 0, 4421, 7020 00, 7309 00, 7310, 7326, 7616, 8436 10 000 0, 8436 21 000 0, 8436 29 000 0, 8436 80 900 0, 8606 91 800 0, 8609 00, 8716 39 800;
Regulation Type: Addendum to Emergency Notification (SPS)
Implementing Guidelines on the Registration of Chemical Pharmaceutical Products for Human Use Applied for Marketing Authorization in accordance with Administrative Order No. 2024-0013 “General Rules and Regulations on the Registration of Pharmaceutical Products and Active Pharmaceutical Ingredients Intended for Human Use”

Distribution date: 05 March 2025 | Final date for Comment: 21 March 2025
Republic Act (RA) No. 9711, otherwise known as the Food and Drug Administration (FDA) Act of 2009, mandated strengthening the FDA as the Philippines' national regulatory agency that shall safeguard public health by ensuring the safety, efficacy, and quality of pharmaceutical products. From this ground stands the continuous action of the agency in developing its systems that are vital in drug product regulation. Moreover, under RA No. 11032, also known as the Ease of Doing Business and Efficient Government Service Delivery Act of 2018, the FDA has inclined itself toward restructuring its procedures to promote efficiency in government service delivery and transparency. Consistent with these laws, Administrative Order (AO) No. 2024-0013, titled "General Rules and Regulations on the Registration of Pharmaceutical Products and Active Pharmaceutical Ingredients for Human Use" was issued. This Order outlines the guidelines for obtaining a Certificate of Product Registration (CPR) for pharmaceutical products, covering marketing authorization, DOH-Use-Only, and foreign donations. It updates the procedures established by AO No. 67 s. 1989, addressing gaps in registration and aligning regulations with current international standards, emphasizing the need to modernize the process for pharmaceutical product registration. AO No. 2024-0013 embodies the different modern frameworks and strategies recommended for the effective evaluation and approval process relevant to reviewing the quality, safety, and efficacy of pharmaceutical products. These include the harmonized regulatory requirements among Association of Southeast Asian Nations (ASEAN) member states through the adoption of the ASEAN Common Technical Dossier (ACTD) and Common Technical Requirements (ACTR), the collaborative procedure for the accelerated registration of World Health Organization (WHO)-prequalified pharmaceutical products, ASEAN Joint Assessment Procedure, and the abridged and verification procedures for the facilitated registration pathways (FRPs). As part of realizing the provisions set forth by AO No. 2024-0013, this Circular hereby provides the implementing guidelines including procedures, standards for evaluation, and requirements for registration applications for the marketing authorization of chemical pharmaceutical products for the guidance of all concerned stakeholders.
Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30); Pharmaceutics (ICS code(s): 11.120)
Regulation Type: Regular notification
Resolución Administrativa N° 0024 /2024 Requisitos y Procedimiento de Autorizacion de Importacion y Exportacion de Productos Regulados por la ANRS (Administrative Resolution No. 0024/2024: Requirements and authorization procedure for the import and export of ANRS-regulated products) (55 pages, in Spanish)

Distribution date: 05 March 2025
The notified Resolution seeks to establish the requirements and authorization procedure for the import and export of ANRS-regulated products. "ANRS-regulated products" encompasses: medicines (breast milk and breast-milk substitutes), vaccines, biological and biotechnological products; natural homoeopathic and medicinal products; food and beverages; nutritional supplements; medical devices; all products relating to ionizing radiation; precursor chemicals; cosmetic and hygiene products; raw materials; chemical reagents and chemical substances; packaging material; laboratory equipment; and tobacco, tobacco products and accessories.The provisions of the notified Resolution shall apply to users engaged in import and export procedures within the various ANRS bodies.G/TBT/N/NIC/182- 2 -
Products Covered: Medicines (breast milk and breast-milk substitutes), vaccines, biological and biotechnological products; natural homoeopathic and medicinal products; food and beverages; nutritional supplements; medical devices; all products relating to ionizing radiation; precursor chemicals; cosmetic and hygiene products; raw materials; chemical reagents and chemical substances; packaging material; laboratory equipment; tobacco, tobacco products and accessories.
Regulation Type: Regular notification
Draft Technical Standard for the Registration of Pharmaceutical Blood Products

Distribution date: 04 March 2025
-__________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: Productos Farmacéuticos
Regulation Type: Addendum to Regular Notification
Standard for Fat Spreads And Blended Spreads.

Distribution date: 04 March 2025 | Final date for Comment: 03 May 2025
(GSO 2229:2021) For Standard for Fat Spreads And Blended Spreads will be amended as following: - Title: Fat Spreads and blended Spreads. - Item No. 1: This GCC standard is concerned with fatty products that contain at least 10 percent and not more than 90 percent of fat, intended primarily for use as spreadable products. It does not apply to: - Fatty spreads derived exclusively from milk and/or milk products to which other substances necessary for processing have been added. - Products in which the fat content is less than 2/3 of the dry matter (excluding salt). -Butter and dairy spreads. - Item No. 2: Adding Technical Regulation GSO 2483:2022 on trans fats” in Complementary References. - Item No. 8/4: Fats of animal origin must be produced from animals in good health at the time of slaughter and fit for human consumption and slaughtered in accordance with the requirements of the Gulf Standard in clause 2/3, (and fats and oils that have undergone modified physical or chemical processes including fractionation, internal esterification or total hydrogenation). - Item No. 4: Add a clause in General Requirements and Quality Requirements 4/12 (Products must be completely free of partially hydrogenated oils.
Products Covered: Edible oils and fats. Oilseeds
Regulation Type: Regular notification
Standard for Fat Spreads And Blended Spreads.

Distribution date: 04 March 2025 | Final date for Comment: 03 May 2025
(GSO 2229:2021) For Standard for Fat Spreads And Blended Spreads will be amended as following: - Title: Fat Spreads and blended Spreads. - Item No. 1: This GCC standard is concerned with fatty products that contain at least 10 percent and not more than 90 percent of fat, intended primarily for use as spreadable products. It does not apply to: - Fatty spreads derived exclusively from milk and/or milk products to which other substances necessary for processing have been added. - Products in which the fat content is less than 2/3 of the dry matter (excluding salt). -Butter and dairy spreads. - Item No. 2: Adding Technical Regulation GSO 2483:2022 on trans fats” in Complementary References. - Item No. 8/4: Fats of animal origin must be produced from animals in good health at the time of slaughter and fit for human consumption and slaughtered in accordance with the requirements of the Gulf Standard in clause 2/3, (and fats and oils that have undergone modified physical or chemical processes including fractionation, internal esterification or total hydrogenation). - Item No. 4: Add a clause in General Requirements and Quality Requirements 4/12 (Products must be completely free of partially hydrogenated oils.
Products Covered: Edible oils and fats. Oilseeds
Regulation Type: Regular notification
Standard for Fat Spreads And Blended Spreads.

Distribution date: 04 March 2025 | Final date for Comment: 03 May 2025
(GSO 2229:2021) For Standard for Fat Spreads And Blended Spreads will be amended as following: - Title: Fat Spreads and blended Spreads. - Item No. 1: This GCC standard is concerned with fatty products that contain at least 10 percent and not more than 90 percent of fat, intended primarily for use as spreadable products. It does not apply to: - Fatty spreads derived exclusively from milk and/or milk products to which other substances necessary for processing have been added. - Products in which the fat content is less than 2/3 of the dry matter (excluding salt). -Butter and dairy spreads. - Item No. 2: Adding Technical Regulation GSO 2483:2022 on trans fats” in Complementary References. - Item No. 8/4: Fats of animal origin must be produced from animals in good health at the time of slaughter and fit for human consumption and slaughtered in accordance with the requirements of the Gulf Standard in clause 2/3, (and fats and oils that have undergone modified physical or chemical processes including fractionation, internal esterification or total hydrogenation). - Item No. 4: Add a clause in General Requirements and Quality Requirements 4/12 (Products must be completely free of partially hydrogenated oils.
Products Covered: Edible oils and fats. Oilseeds
Regulation Type: Regular notification
Standard for Fat Spreads And Blended Spreads.

Distribution date: 04 March 2025 | Final date for Comment: 03 May 2025
(GSO 2229:2021) For Standard for Fat Spreads And Blended Spreads will be amended as following: - Title: Fat Spreads and blended Spreads. - Item No. 1: This GCC standard is concerned with fatty products that contain at least 10 percent and not more than 90 percent of fat, intended primarily for use as spreadable products. It does not apply to: - Fatty spreads derived exclusively from milk and/or milk products to which other substances necessary for processing have been added. - Products in which the fat content is less than 2/3 of the dry matter (excluding salt). -Butter and dairy spreads. - Item No. 2: Adding Technical Regulation GSO 2483:2022 on trans fats” in Complementary References. - Item No. 8/4: Fats of animal origin must be produced from animals in good health at the time of slaughter and fit for human consumption and slaughtered in accordance with the requirements of the Gulf Standard in clause 2/3, (and fats and oils that have undergone modified physical or chemical processes including fractionation, internal esterification or total hydrogenation). - Item No. 4: Add a clause in General Requirements and Quality Requirements 4/12 (Products must be completely free of partially hydrogenated oils.
Products Covered: Edible oils and fats. Oilseeds
Regulation Type: Regular notification
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