Regulatory Updates

Proposed amendments to the “Regulation on Evaluation of Food and Drug Testing and Inspection Agencies” 

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Distribution date: 18 September 2025 | Final date for Comment: 17 November 2025

This amendment aims to revise the evaluation items to assess the capabilities of testing and inspection laboratories for hygiene products, as oral care products and tattoo dyes shall be included as cleansing and hygiene products from 14th June 2025 due to the amendment to the “Cleansing and Hygiene Products Control Act.”

Products Covered: Hygiene products

Regulation Type: Regular notification

Reglamento Técnico para la Gestión Sanitaria y Ambiental de los Bifenilos Policlorados (Technical Regulation for the health and environmental management of polychlorinated biphenyls)

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Distribution date: 17 September 2025

Pursuant to Supreme Decree No. 018-2025-SA, the Ministry of Health of Peru approves and publishes the Technical Regulation for the Sanitary and Environmental Management of Polychlorinated Biphenyls, which was notified in document G/TBT/N/PER/106 dated 28 August 2018.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: Subheading Description 2710.19.33.00 Electrical insulation oils 2710.91.00.00 Waste oils containing polychlorinated biphenyls (PCBs) 3824.82.00.00 Mixtures and preparations containing polychlorinated biphenyls (PCBs) 8504.21.19.00 Liquid dielectric transformers, having a power handling capacity not exceeding 10 kVA 8504.21.90.00 Liquid dielectric transformers, having a power handling capacity above 10 kVA but not exceeding 650 kVA 8504.22.10.00 Liquid dielectric transformers, having a power handling capacity above 650 kVA but not exceeding 1000 kVA 8504.22.90.00 Liquid dielectric transformers, having a power handling capacity above 1000 kVA but not exceeding 10,000 kVA 8504.23.00.00 Liquid dielectric transformers, having a power handling capacity above 10,000 kVA 8532.10.00.00 Fixed capacitors designed for use in 50/60 Hz circuits and having a reactive power handling capacity of not less than 0.5 kvar (power capacitors) 3824.81.00.00 Mixtures and preparations containing oxirane (ethylene oxide) 3824.82.00.00 Mixtures and preparations containing polybrominated biphenyls (PBBs), polychlorinated biphenyls (PCBs) or polychlorinated terphenyls (PCTs) 3824.83.00.00 Mixtures and preparations containing tris (2,3-dibromopropyl) phosphate 3822.00.30.00 Certified reference materials

Regulation Type: Addendum to Regular Notification

Draft COMMISSION REGULATION (EU) …/…of XXX amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards lead in ammunition and fishing tackle

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Distribution date: 17 September 2025 | Final date for Comment: 16 November 2025

This draft Regulation intends to introduce a new entry to Annex XVII to Regulation (EC) No 1907/2006. It intends to restrict the use and, in certain cases, the placing on the market of ammunition and fishing tackle containing lead in a concentration equal to or greater than 1% by weight. It provides for several derogations, including for sports shooting in shooting ranges (conditional to the installation of measures for lead containment and recovery, for ranges where lead gunshot is used) or for uses that pose a limited risk to the environment or where suitable alternatives are not available (e.g. historical firearms, traditional marksmen festivals, bullets and lures containing copper or copper alloys, split shot, etc.). The application of the proposed Regulation is deferred for most of the uses and sectors concerned, in order to allow stakeholders sufficient time to comply with the new measures and transition to suitable alternatives. The proposed transitional periods range between 6 months (e.g. drop-in sinkers and fishing wires) and 10 years (e.g. centrefire bullets of calibre < 5.6 mm and rimfire bullets for hunting). Military and security uses of lead ammunition, as well as indoor uses, are excluded from the scope of the restriction.

Products Covered: Ammunition and fishing tackle containing lead in concentration ≥ 1% w/w. 

Regulation Type: Regular notification

Revision of the Order for Enforcement of the Act on the Regulation of Manufacture and Evaluation of Chemical Substances

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Distribution date: 17 September 2025 | Final date for Comment: 16 November 2025

Based on Article 17 and 22 of the Act on the Regulation of Manufacture and Evaluation of Chemical Substances (hereinafter referred to as the “Act”), the following will be designated as Class I Specified Chemical Substances which need authorization to be manufactured or imported.Perfluoro (hexane-1-sulfonic acid) (PFHxS)-related compounds Based on Article 24 of the Act, the following will be designated as products prohibited from being imported when PFHxS-related compounds are used in them. 1. Water-repellent textiles and oil-repellent textiles2. Etching agents used for metal processing3. Etchants used in the manufacture of semiconductors4. Surface treatment agents for plating or such preparation additives5. Antireflection agents used in semiconductor manufacturing6. Resists for semiconductors7. Water repellent, oil repellent and fabric protection agents8. Fire extinguishers, fire-extinguishing agents, and fire-extinguishing foam9. Water-repellent clothes and oil-repellent clothes10. Water-repellent floor coverings and oil-repellent floor coverings

Products Covered: The following chemical substances・Perfluoro (hexane-1-sulfonic acid) (PFHxS)-related compounds The following products in which PFHxS-related compounds are used1. Water-repellent textiles and oil-repellent textiles2. Etching agents used for metal processing3. Etchants used in the manufacture of semiconductors4. Surface treatment agents for plating or such preparation additives5. Antireflection agents used in semiconductor manufacturing6. Resists for semiconductors7. Water repellent, oil repellent and fabric protection agents8. Fire extinguishers, fire-extinguishing agents, and fire-extinguishing foam9. Water-repellent clothes and oil-repellent clothes10. Water-repellent floor coverings and oil-repellent floor coverings

Regulation Type: Regular notification

Protection of Public Health Regulations (Food) (Import of dietary supplements by a Proper Importer) 5783-2024

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Distribution date: 15 September 2025

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Products Covered: Dietary supplements (HS code(s): 3004); (ICS code(s): 11.120.10; 67.040)

Regulation Type: Addendum to Regular Notification

Food standards

Proyecto de Real Decreto por el que se regula el etiquetado accesible de productos de consumo.

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Distribution date: 15 September 2025 | Final date for Comment: 14 November 2025

El presente reglamento contiene disposiciones a nivel de etiquetado de productos de consumo. Las previsiones contenidas en el presente real decreto se aplicarán a los bienes y productos de consumo de especial relevancia para la protección de la seguridad, integridad y calidad de vida de las personas con discapacidad incluidos en el Anexo de esta norma que se comercialicen en España, con independencia del lugar o canal de puesta a disposición de la persona consumidora o usuaria final, quedando fuera del ámbito de aplicación los productos de uso exclusivamente industrial o profesional, así como la venta de productos a granel, de productos que no tengan envase o de productos envasados en punto de venta o a petición de la clientela.

Products Covered: Productos cosméticos, según la definición dada en el Reglamento (CE) 1223/2009 del Parlamento Europeo y del Consejo de 30 de noviembre de 2009 sobre los productos cosméticos y de cuidado personal, en lo que resulte aplicable del Real Decreto 1599/1997, de 17 de octubre, sobre productos cosméticos.Sustancias y mezclas peligrosas de acuerdo con el Anexo I del Reglamento (CE) No 1272/2008, del Parlamento Europeo y del Consejo, de 16 de diciembre de 2008, sobre clasificación, etiquetado y envasado de sustancias y mezclas, y por el que se modifican y derogan las Directivas 67/548/CEE y 1999/45/CE y se modifica el Reglamento (CE) no 1907/2006.Productos alimenticios, tal como vienen definidos en el Reglamento (CE) nº 178/2002 del Parlamento Europeo y del Consejo, de 28 de enero de 2002, por el que se establecen los principios y los requisitos generales de la legislación alimentaria, se crea la Autoridad Europea de Seguridad Alimentaria y se fijan procedimientos relativos a la seguridad alimentaria.Productos alimenticios que contengan uno o varios de los ingredientes o coadyuvantes tecnológicos que figuran en el anexo II del Reglamento (UE) no 1169/2011 del Parlamento Europeo y del Consejo, de 25 de octubre de 2011, sobre la información alimentaria facilitada al consumidor y por el que se modifican los Reglamentos (CE) no 1924/2006 y (CE) no 1925/2006 del Parlamento Europeo y del Consejo, y por el que se derogan la Directiva 87/250/CEE de la Comisión, la Directiva 90/496/CEE del Consejo, la Directiva 1999/10/CE de la Comisión, la Directiva 2000/13/CE del Parlamento Europeo y del Consejo, las Directivas 2002/67/CE, y 2008/5/CE de la Comisión, y el Reglamento (CE) no 608/2004 de la Comisión, o derive de una sustancia o producto que figure en dicho anexo que cause alergias o intolerancias y se utilice en la fabricación o la elaboración del producto alimenticio y siga estando presente en el producto acabado, aunque sea en una forma modificada.

Regulation Type: Regular notification

Labelling

DEAS 1279: 2025, Metal roofing tiles - Specification, First Edition  

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Distribution date: 15 September 2025 | Final date for Comment: 14 November 2025

This Draft East African Standard specifies requirements, sampling, inspection and test methods for granulated metal roofing tiles, coated or uncoated, supplied in the form of carbon steel sheets or aluminium alloy sheets (each comprising a series of simulated tile units) and for trim sections designed for use in conjunction with tile units of the same material and of appropriate profile.

Products Covered: Flat-rolled products of iron or non-alloy steel, of a width of >= 600 mm, hot-rolled or cold-rolled "cold-reduced", electrolytically plated or coated with zinc (HS code(s): 721030); Flat-rolled products of iron or non-alloy steel, of a width of >= 600 mm, hot-rolled or cold-rolled "cold-reduced", plated or coated with aluminium-zinc alloys (HS code(s): 721061); Flat-rolled products of iron or non-alloy steel, of a width of >= 600 mm, hot-rolled or cold-rolled "cold-reduced", clad, plated or coated (excl. tinned, plated or coated with lead, zinc, chromium oxides, chromium and chromium oxides, or aluminium, painted, varnished or coated with plastics) (HS code(s): 721090); Other construction materials (ICS code(s): 91.100.99)

Regulation Type: Regular notification

PCD 733:2025, Textiles – Islamic prayer rugs – Specification, First edition

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Distribution date: 15 September 2025 | Final date for Comment: 14 November 2025

This Zanzibar National Standard specifies requirements, sampling and test methods for Islamic prayer rugs.

Products Covered: Products of the textile industry (ICS code(s): 59.080)

Regulation Type: Regular notification

DEAS 1279: 2025, Metal roofing tiles - Specification, First Edition  

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Distribution date: 15 September 2025 | Final date for Comment: 14 November 2025

This Draft East African Standard specifies requirements, sampling, inspection and test methods for granulated metal roofing tiles, coated or uncoated, supplied in the form of carbon steel sheets or aluminium alloy sheets (each comprising a series of simulated tile units) and for trim sections designed for use in conjunction with tile units of the same material and of appropriate profile.

Products Covered: Flat-rolled products of iron or non-alloy steel, of a width of >= 600 mm, hot-rolled or cold-rolled "cold-reduced", electrolytically plated or coated with zinc (HS code(s): 721030); Flat-rolled products of iron or non-alloy steel, of a width of >= 600 mm, hot-rolled or cold-rolled "cold-reduced", plated or coated with aluminium-zinc alloys (HS code(s): 721061); Flat-rolled products of iron or non-alloy steel, of a width of >= 600 mm, hot-rolled or cold-rolled "cold-reduced", clad, plated or coated (excl. tinned, plated or coated with lead, zinc, chromium oxides, chromium and chromium oxides, or aluminium, painted, varnished or coated with plastics) (HS code(s): 721090); Other construction materials (ICS code(s): 91.100.99)

Regulation Type: Regular notification

DEAS 1279: 2025, Metal roofing tiles - Specification, First Edition  

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Distribution date: 15 September 2025 | Final date for Comment: 14 November 2025

This Draft East African Standard specifies requirements, sampling, inspection and test methods for granulated metal roofing tiles, coated or uncoated, supplied in the form of carbon steel sheets or aluminium alloy sheets (each comprising a series of simulated tile units) and for trim sections designed for use in conjunction with tile units of the same material and of appropriate profile.

Products Covered: Flat-rolled products of iron or non-alloy steel, of a width of >= 600 mm, hot-rolled or cold-rolled "cold-reduced", electrolytically plated or coated with zinc (HS code(s): 721030); Flat-rolled products of iron or non-alloy steel, of a width of >= 600 mm, hot-rolled or cold-rolled "cold-reduced", plated or coated with aluminium-zinc alloys (HS code(s): 721061); Flat-rolled products of iron or non-alloy steel, of a width of >= 600 mm, hot-rolled or cold-rolled "cold-reduced", clad, plated or coated (excl. tinned, plated or coated with lead, zinc, chromium oxides, chromium and chromium oxides, or aluminium, painted, varnished or coated with plastics) (HS code(s): 721090); Other construction materials (ICS code(s): 91.100.99)

Regulation Type: Regular notification

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