Regulatory Updates

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

Distribution date: 21 August 2025 | Final date for Comment: 03 October 2025

The draft amendments to the Requirements for the implementation, maintenance and evaluation of the quality management system of medical devices, depending on the potential risk of their use, apply to medical devices put into circulation in the territory of the Eurasian Economic Union and provide for the following: the possibility, in certain situations, of confirming the compliance of the production conditions of the sterilization site with the established requirements without the inspection organization visiting the sterilization site, which will avoid repeating individual procedures when evaluating the quality management system in order to rationalize the resources of manufacturers of medical devices and inspecting organizations.

Products Covered: Cotton wool, gauze, bandages and similar articles (for example, bandages, Band-Aids, poultices), impregnated or coated with pharmaceutical substances or packaged in forms or packages for retail sale, intended for use in medicine, surgery, dentistry or veterinary medicine (HS 3005); Devices and instruments used in medicine, surgery, dentistry or veterinary medicine, including scintigraphic equipment, other electro-medical equipment and vision testers (HS 9018); Equipment based on the use of X-ray, alpha, beta or gamma radiation, intended or not intended for medical, surgical, dental or veterinary use, including X-ray or radiotherapy equipment, X-ray tubes and other X - ray generators, high-voltage generators, shields and control panels, screens, tables, chairs and similar products for examination or treatment (HS 9022); Medical, surgical, dental or veterinary furniture (for example, operating tables, examination tables, hospital beds with mechanical devices, dental chairs); barber chairs and similar chairs with devices for rotating and simultaneously for tilting and lifting; parts of the above-mentioned products (HS Code 9402).

Regulation Type: Regular notification

Distribution date: 21 August 2025 | Final date for Comment: 20 October 2025

Proposal of Conformity Assessment Requirements and Specifications for the Conformity Identification Mark for Graphene Characterization. Criticisms and suggestions should be presented on the Participa + Brasil Platform: https://www.gov.br/participamaisbrasil/inmetro-diretoria-de-avaliacao-da-conformidade

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

Regulation Type: Regular notification

Distribution date: 21 August 2025 | Final date for Comment: 05 October 2025

The Therapeutic Goods Administration (TGA) has initiated a public consultation on proposed amendments to the Poisons Standard, aimed at enhancing the regulation of certain sunscreen ingredients and related substances. These proposals have been developed to ensure the safe use of chemicals in therapeutic and cosmetic sunscreens, while maintaining consistency across Australian jurisdictions.The consultation focuses on three substances:HomosalateOxybenzoneBenzophenone (as an impurity/degradant)These substances are being considered for rescheduling based on emerging scientific evidence and international regulatory trends. The proposed amendments include options for: restrictions on the maximum concentration of these substances in sunscreens restrictions based on application to parts of the body restrictions based on age of the consumerThe proposed amendments have been referred to the Joint Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) at a meeting to be held on 17 September 2025. Following the public consultation and subsequent recommendations and advice from the Joint ACMS-ACCS, the delegate of the Secretary of the Department of Health, Disability and Ageing will make an interim decision. The Interim Decision that may incorporate one or more of the options (with modification) for each substance. Neither the TGA nor the Delegate have formed a view at this time as to which options should be implemented or are preferred. The consultation was open to public comment until 12 August 2025, and all submissions will inform the delegate’s interim decision.

Products Covered: HomosalateOxybenzone Benzophenone

Regulation Type: Regular notification

Distribution date: 15 August 2025 | Final date for Comment: 25 August 2025

The production, registration, licensing and import permits for organic fertilizers are administered by the Ministry of Agriculture and Forestry, and these procedures are carried out within the framework of the ‘Regulation on Organic, Mineral and Microbial Fertilizers Used in Agriculture’.The provisions relating to the aforementioned permits have been reviewed and updated in line with the comments of the fertilizer sector. The duties and authorities of the Authorized Commission have been updated, a confidentiality agreement has been introduced, and license documents have been classified to set limits on contract manufacturing.In addition, fertilizer contents and their limit values have been updated, and it is envisaged that new analysis methods will be applied to determine the contents in detail. 

Products Covered: NP(Nitrogen and phosphorus)  and NPK (Nitrogen, phosphorus, and potassium) Organomineral Fertilizer

Regulation Type: Addendum to Regular Notification