Regulatory Updates
Reglamento de la Ley N° 31182, Ley que protege la salud e integridad física de las personas del contenido de plomo en pinturas y otros materiales de revestimiento (Regulation implementing Law No. 31182 protecting the health and physical integrity of people from lead content in paints and other coating materials)
Distribution date: 19 June 2025
The Regulation implementing Law No. 31182 protecting the health and physical integrity of people from lead content in paints and other coating materials has been approved pursuant to Supreme Decree No. 007-2025-SA, published on 3 June 2025, and will enter into force six months after its publication in the Official Journal, El Peruano.Ministerio de Comercio Exterior y Turismo, MINCETUR (Ministry of Foreign Trade and Tourism)Calle Uno Oeste Nº 50 - Urb. Corpac - Lima 27 - PeruTel.: (+51-1) 513-6100, Ext. 1223 and 1239Email: otc@mincetur.gob.pe__________
Products Covered: Paints (HS Chapters 3208, 3209, 3210, 3112, 3213 and 3214) and other coating materials.
Regulation Type: Addendum to Regular Notification
Modificaciones al Reglamento de Establecimientos Farmacéuticos (Amendments to the regulations on pharmaceutical establishments)
Distribution date: 19 June 2025
Supreme Decree No. 008-2025-SA amends Articles 23, 94, 110, 123, 124, 125, 127, 128, 129, 135(d) and 137 of the regulations on pharmaceutical establishments approved by Supreme Decree No. 014-2011-SA, which entered into force the day following publication in Official Journal El Peruano.Ministerio de Comercio Exterior y Turismo, MINCETUR (Ministry of Foreign Trade and Tourism)Calle Uno Oeste Nº 50 - Urb. Corpac - Lima 27 - PeruTel.: (+51-1) 513-6100, Ext. 1223 and 1239Email: otc@mincetur.gob.pe__________
Products Covered: Pharmaceutical products: Medicine, herbal medicine, dietary products and sweeteners, and biological and galenic products (classified under Chapter 30 of the Harmonized System or in the Customs Tariff); Medical devices (falling within tariff headings 9018, 9019, 9021, 9022 and 9402 of the Harmonized System or Customs Tariff); Sanitary products: Cosmetics, domestic hygiene products and absorbent personal hygiene products (falling within the following tariff headings of the Harmonized System or Customs Tariff: 3303, 3304, 3305, 3401, 3402, 4818, 5601, subheading 3808.91.3401, 3402, 3809.91.00, 4818 and 5601)
Regulation Type: Addendum to Regular Notification
National Standard of the P.R.C., Chinese common name for pesticides
Distribution date: 18 June 2025 | Final date for Comment: 17 August 2025
This document specifies the Chinese common names for those pesticides that used both domestically and internationally.This document applies to all activities within the territory of China related to pesticide management, scientific research, production, distribution, application, public health and epidemic prevention, environmental protection, publication compilation, advertising and publicity, etc. Whenever pesticide names are mentioned in these contexts, the Chinese common names specified in this standard shall be used for expression.
Products Covered: Pesticides(insecticide, fungicide, herbicide and plant growth regulator)(HS code(s): 380891; 380892; 380893); (ICS code(s): 65.100)
Regulation Type: Regular notification
Regulations on pharmaceutical establishments
Distribution date: 18 June 2025
Pursuant to Supreme Decree No. 014-2011-SA, published on 27 July 2011, the regulations on pharmaceutical establishments have been approved, and will enter into force 180 days after publication in the Official Journal El Peruano.Ministerio de Comercio Exterior y Turismo, MINCETUR (Ministry of Foreign Trade and Tourism)Calle Uno Oeste Nº 50 - Urb. Corpac - Lima 27 - PeruTel.: (+51-1) 513-6100, Ext. 1223 and 1239Email: otc@mincetur.gob.pe__________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: Pharmaceutical products: Medicine, herbal medicine, dietary products and sweeteners, and biological and galenic products (classified under Chapter 30 of the Harmonized System or in the Customs Tariff); Medical devices (falling within tariff headings 9018, 9019, 9021, 9022 and 9402 of the Harmonized System or Customs Tariff); Sanitary products: Cosmetics, domestic hygiene products and absorbent personal hygiene products (falling within the following tariff headings of the Harmonized System or Customs Tariff: 3303, 3304, 3305, 3401, 3402, 4818, 5601, subheading 3808.91.3401, 3402, 3809.91.00, 4818 and 5601)
Regulation Type: Addendum to Regular Notification
Draft Resolution number 1114, 06 September 2022.
Distribution date: 17 June 2025
The Draft Resolution number 1114, 06 September 2022 - previously notified through G/TBT/N/BRA/1446 - which establishes technical requirements for the inclusion or alteration of substances in the list of preservatives that are allowed in the manufacturing of sanitizing products, was adopted as Normative Instruction- NI number 368, 20 June 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=00000368&sgl_tipo=INM&sgl_orgao=DC/ANVISA/MS&vlr_ano=2025&seq_ato=000&cod_modulo=134&cod_menu=1696
Products Covered: FOOD TECHNOLOGY (ICS code(s): 67)
Regulation Type: Addendum to Regular Notification
Letter of the Committee for Veterinary Control and Surveillance of the Ministry of Agriculture of Kazakhstan on the introduction of temporary restrictions on the importation to the territory of Kazakhstan from the Northern Ireland of the United Kingdom of Great Britain and Northern Ireland of live poultry and hatching eggs, down and feathers, poultry meat and all types of poultry products that have not undergone heat treatment, feed and feed additives for birds, hunting trophies that have not undergone taxidermy, used equipment for keeping, slaughtering and cutting birds, as well as transit from the above-mentioned territory through the territory of Kazakhstan of live birds
Distribution date: 17 June 2025
The Committee for Veterinary Control and Surveillance of the Ministry of Agriculture of Kazakhstan reports that on the basis of the official notification of the World Organisation for Animal Health (WOAH), an outbreak of avian influenza virus was registered in the Northern Ireland of the United Kingdom of Great Britain and Northern Ireland. In this regard, since 26 February 2025, temporary restrictions have been introduced on the importation and transit to the territory of Kazakhstan from the territory of the Northern Ireland of the United Kingdom of Great Britain and Northern Ireland of live poultry and hatching eggs, down and feathers, poultry meat and all types of poultry products that have not undergone heat treatment (at least 70 °C), feed and feed additives for birds (with the exception of feed additives of plant origin, chemical and microbiological synthesis), hunting trophies that have not undergone taxidermy (game birds), used equipment for keeping, slaughtering and cutting birds, as well as transit of live poultry from the above-mentioned territory through the territory of Kazakhstan.
Products Covered: Live poultry and hatching eggs, down and feathers, poultry meat and all types of poultry products, feed and feed additives for birds, hunting trophies, used equipment for keeping, slaughtering and cutting birds
Regulation Type: Emergency notifications (SPS)
Letter of the Committee for Veterinary Control and Surveillance of the Ministry of Agriculture of Kazakhstan on the introduction of temporary restrictions on the importation and transit to the territory of Kazakhstan from the Durres region of Albania of live poultry and hatching eggs, down and feathers, poultry meat and all types of poultry products that have not undergone heat treatment, feed and feed additives for birds, hunting trophies that have not undergone taxidermy, used equipment for keeping, slaughtering and cutting birds
Distribution date: 17 June 2025
The Committee for Veterinary Control and Surveillance of the Ministry of Agriculture of Kazakhstan reports that on the basis of the official notification of the World Organisation for Animal Health (WOAH), an outbreak of avian influenza virus was registered in the Durres region of Albania. In this regard, since 8 March 2025, temporary restrictions have been introduced on the importation and transit to the territory of Kazakhstan from the territory of the Durres region of Albania of live poultry and hatching eggs, down and feathers, poultry meat and all types of poultry products that have not undergone heat treatment (at least 70 °C), feed and feed additives for birds (with the exception of feed additives of plant origin, chemical and microbiological synthesis), hunting trophies that have not undergone taxidermy (game birds), used equipment for keeping, slaughtering and cutting birds.
Products Covered: Live poultry and hatching eggs, down and feathers, poultry meat and all types of poultry products, feed and feed additives for birds, hunting trophies, used equipment for keeping, slaughtering and cutting birds
Regulation Type: Emergency notifications (SPS)
Letter of the Committee for Veterinary Control and Surveillance of the Ministry of Agriculture of Kazakhstan on the introduction of temporary restrictions on the importation and transit to the territory of Kazakhstan from the County of Skåne of Sweden of live poultry and hatching eggs, down and feathers, poultry meat and all types of poultry products that have not undergone heat treatment, feed and feed additives for birds, hunting trophies that have not undergone taxidermy, used equipment for keeping, slaughtering and cutting birds
Distribution date: 17 June 2025
The Committee for Veterinary Control and Surveillance of the Ministry of Agriculture of Kazakhstan reports that on the basis of the official notification of the World Organisation for Animal Health (WOAH), an outbreak of avian influenza virus was registered in the County of Skåne of Sweden. In this regard, since 5 March 2025, temporary restrictions have been introduced on the importation and transit to the territory of Kazakhstan from the territory of the County of Skåne of Sweden of live poultry and hatching eggs, down and feathers, poultry meat and all types of poultry products that have not undergone heat treatment (at least 70 °C), feed and feed additives for birds (with the exception of feed additives of plant origin, chemical and microbiological synthesis), hunting trophies that have not undergone taxidermy (game birds), used equipment for keeping, slaughtering and cutting birds.
Products Covered: Live poultry and hatching eggs, down and feathers, poultry meat and all types of poultry products, feed and feed additives for birds, hunting trophies, used equipment for keeping, slaughtering and cutting birds
Regulation Type: Emergency notifications (SPS)
Draft Resolution of the Cabinet of Ministers of Ukraine “On Approval of the Rules for Joint Submission of Information in Applications for State Registration of Identical Chemical Substances”
Distribution date: 16 June 2025 | Final date for Comment: 15 August 2025
The proposed Rules establish the requirements for the joint submission of information in applications for the state registration of identical chemical substances. These Rules apply to all business entities, regardless of their form of ownership, that have submitted applications for the state registration of identical chemical products. In accordance with these Rules, and in line with Technical Regulation on the Safety of Chemical Products (notification G/TBT/N/UKR/179/Rev.2/Add.1), for joint submission of information in applications for the state registration of identical chemical substances applicants shall:- establish an information exchange consortium or join an existing one;- designate a lead applicant;- submit an official notification to the Ministry of Environmental Protection and Natural Resources regarding the establishment of the information exchange consortium, indicating the contact details of all applicants and the designated lead applicant. Within 10 working days of the consortium's establishment, the lead applicant shall submit a joint notification to the Ministry of Environmental Protection and Natural Resources, in either paper or electronic form. The joint notification shall be accompanied by documents that comply with the requirements set out in the Technical Regulation, specifically;- data on the hazard classification of the chemical substance;- a summary of studies on the hazardous properties of the chemical substance, including descriptions of objectives, methods, results and conclusions;- a chemical safety report resulting from the conducted chemical safety assessment, or information on exposure levels to human health and/or the environment, in cases where a chemical safety assessment is not required;- proposals for conducting new tests on the chemical substance, if the results of such tests are necessary to carry out the chemical safety assessment.
Products Covered: Chemical products (substances, mixtures, explosive or pyrotechnical articles). All HS codes from Chapters 28 - 38 of Section VI of the Harmonized System, excluding Chapter 30 -Pharmaceutical products
Regulation Type: Regular notification
Proyecto de Resolución "Por la cual se crea el banco de vacunas de Influenza Aviar como parte de una estrategia de control destinado a interrumpir la transmisión del virus de Influenza Aviar de Alta Patogenicidad en Estados de Emergencia Sanitaria que sean declarados por el ICA en el territorio nacional, como consecuencia de la presencia de brotes de la enfermedad y se dictan otras disposiciones" (Draft Resolution creating the avian influenza vaccine bank as part of a control strategy aimed at interrupting the transmission of the high pathogenicity avian influenza virus in states of health emergency declared by the ICA within the national territory, in response to outbreaks of the disease, and issuing other provisions)
Distribution date: 13 June 2025 | Final date for Comment: 12 August 2025
The notified draft Resolution creates the avian influenza vaccine bank as part of a control strategy aimed at interrupting the transmission of the high pathogenicity avian influenza virus in states of health emergency declared by the ICA within the national territory, in response to outbreaks of the disease, and issuing other provisions. The established provisions shall apply to all natural or legal persons who have a valid ICA registration as an importer of veterinary biologics, as well as to those who market, store and/or use the vaccine within the national territory.
Products Covered: Avian influenza vaccines (HS code: 300242)
Regulation Type: Regular notification
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