Regulatory Updates

Distribution date: 05 September 2025

The Food and Drug Administration (FDA or we) is amending the food additive regulation to provide for the safe use of hydrogen peroxide in food as an antimicrobial agent, oxidizing and reducing agent, and bleaching agent, and to remove sulfur dioxide. We are taking this action in response to a food additive petition filed by Cargill, Inc. (Cargill or petitioner). This order is effective 3 September 2025. The incorporation by reference of certain material listed in the order is approved by the Director of the Federal Register as of 3 September 2025. 

Products Covered: Hydrogen peroxide, whether or not solidified with urea. (HS code(s): 2847); Food Technology (ICS code(s): 67)

Regulation Type: Addendum to Regular Notification

Distribution date: 04 September 2025 | Final date for Comment: 03 November 2025

 The draft Decree comprises 10 chapters and 60 articles, establishing a comprehensive regulatory framework for the management of cosmetics. It provides detailed provisions on the export and import of cosmetic products, the issuance of Certificates of Free Sale (CFS), and requirements for Product Information Files (PIF), labeling, and advertising in line with ASEAN guidelines and the Law on Advertising. The Decree also introduces online procedures for product notification and dossier archiving.Furthermore, it regulates the inspection and supervision of cosmetic safety and quality, including dossier reviews, product sampling, and testing. It stipulates the circumstances under which cosmetics may be suspended, recalled, or destroyed, and outlines measures for handling non-compliant products. Finally, the Decree assigns responsibilities to ministries, agencies, organizations, and individuals involved in implementation, while also setting forth transitional provisions, the effective date, and enforcement mechanisms.

Products Covered: Cosmetics

Regulation Type: Regular notification

Distribution date: 04 September 2025 | Final date for Comment: 03 November 2025

This standard is applicable to the food additive copper sulfate pentahydrate produced by the reaction of copper oxide and sulfuric acid, as well as anhydrous copper sulfate that has been dried to remove crystal water.

Products Covered: Food additive Copper sulfate

Regulation Type: Regular notification

Distribution date: 01 September 2025

Proposal for the additional designation of 3 substances as Shitei Yakubutsu, and their proper uses under the Act.

Products Covered: Substances with probable effects on the central nervous system

Regulation Type: Regular notification

Distribution date: 01 September 2025

The notified measure seeks to prohibit the importation of fertilizers and biostimulants made from, or containing, proteins derived from ruminant protein meals.Ruminant protein meals shall be understood to mean any final or intermediate solid product that contains proteins, obtained during the processing of ruminant animal tissues, excluding peptides with a molecular mass of less than 10,000 Daltons, and amino acids.In addition, it establishes measures for fertilizers and biostimulants made from, or containing, ruminant protein meals that are held in distribution or sales locations in the national territory when the resolution comes into effect.Further details can be found in the document attached to this notification.

Products Covered: Fertilizers and biostimulants containing proteins derived from ruminant protein meals

Regulation Type: Regular notification

Distribution date: 27 August 2025

Draft Resolution 776 of 7 February 2020 - previously notified through G/TBT/N/BRA/968 - which establishes the regulation with technical requirements for the market authorization, modifications and classification of sanitizing products, according to their potential risk to the health., was adopted as Resolution - RDC number 989, 15 August 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=00000989&sgl_tipo=RDC&sgl_orgao=RDC/DC/ANVISA/MS&vlr_ano=2025&seq_ato=000&cod_modulo=134&cod_menu=1696 

Products Covered: HS Code(s): 3402; 340119; 340120; 330290 (sanitizing products).

Regulation Type: Addendum to Regular Notification

Distribution date: 27 August 2025 | Final date for Comment: 24 September 2025

Establishes restrictions on the use of certain hazardous substances in electrical and electronic equipment sold in the national territory, and includes other provisions. Criticisms and suggestions should be presented on the Participa + Brasil Platform: https://www.gov.br/participamaisbrasil/inmetro-diretoria-de-avaliacao-da-conformidade

Products Covered: INORGANIC CHEMICALS; ORGANIC OR INORGANIC COMPOUNDS OF PRECIOUS METALS, OF RARE-EARTH METALS, OF RADIOACTIVE ELEMENTS OR OF ISOTOPES (HS code(s): 28); Electrical engineering (ICS code(s): 29)

Regulation Type: Regular notification

Distribution date: 25 August 2025 | Final date for Comment: 24 October 2025

Format of veterinary health certificate for import of gelatine derived from the bones or skins of bovine/porcine (other than wild/feral) into India.

Products Covered: Gelatine and products thereof

Regulation Type: Regular notification

Distribution date: 25 August 2025

Republication of Public Consultation No. 22, 19 August 2025, due to an inaccuracy found in the original in Edition No. 157, of the Official Gazette of the Union on 20 August 2025, Section 1, page 18.  https://www.in.gov.br/en/web/dou/-/consulta-publica-n-22-de-19-de-agosto-de-2025-*-649881380

Products Covered: Carbon (carbon blacks and other forms of carbon not elsewhere specified or included). (HS code(s): 2803)

Regulation Type: Corrigendum to Regular Notification

Distribution date: 22 August 2025 | Final date for Comment: 21 October 2025

The document is to standardize the record-filing of internet information services for durgs and medical devices and enhance the management of such services.

Products Covered: Drugs and Medical devices (HS code(s): 30; 90); (ICS code(s): 11)

Regulation Type: Regular notification