Regulatory Updates

Distribution date: 19 September 2025 | Final date for Comment: 30 December 2025

The purpose of this Notice of Consultation is to provide an opportunity for the public and other interested stakeholders to comment on the proposal to revise the listing for "Melatonin or its salts" on the human use part of the Prescription Drug List (PDL). Specifically, the proposal is to broaden the qualifier to capture all sleep-related uses in the pediatric population (i.e., all children and adolescents under 18 years of age).

Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)

Regulation Type: Regular notification

Distribution date: 19 September 2025 | Final date for Comment: 18 November 2025

This draft Commission Implementing Decision repeals the postponements of the expiry dates of the approval of etofenprox for use in biocidal products of product types (PT) 8 and 18.On 27 July 2018, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of etofenprox for use in biocidal products of product-type 8.On 25 October 2023, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of etofenprox for use in biocidal products of product-type 18.On 12 June 2025, the applicant informed the Commission that it had withdrawn their applications for the renewal of approval of etofenprox for both product-types of 8 and 18. Consequently, a draft Decision is being prepared to not renew the approval of etofenprox for PT 8 and 18. Further to that Decision, it is necessary to repeal the postponements of the expiry dates of the approval of etofenprox for PT 8 and 18. The present draft Decision therefore intends to repeal Decisions (EU) 2022/1487 and (EU) 2025/434 for PT 8 and 18, respectively. 

Products Covered: Biocidal products

Regulation Type: Regular notification

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

The Ministry of Food and Drug Safety (MFDS) is amending the “Regulations on Fees for Pharmaceutical Approval, etc.” as follows: A. Increase in application fees for biosimilar products approval and preliminary review (3 and 26 of Annex 1 in the Draft) The fees that have been applied to new biologics are separately classified as biosimilar products. The fee for manufacturing authorization (MA) is increased from 8.03 million won (approximately $5,782) to 310 million won (approximately $223,246), and the fee for preliminary safety/efficacy review from 3.01 million won (approximately $2,167) to 155 million won (approximately $111,623), to reflect actual circumstances. B. Fee reduction for biosimilar products from small and medium-sized enterprises (newly established Article 2 (4) (c) in the Draft)To reduce the fees for biosimilar products developed by small and medium-sized enterprises in Korea by 50%.  C. Fee reduction of the second MA application for biosimilar products by the same applicant (3 and 26 of Annex 1 in the Draft)When the same applicant files the second application for a different dosage or injection dosage form (including vial, ampule, Pen) for the newly established biosimilar product fee, the current fees for new biologics are applied from the second application.  

Products Covered: (HS code(s): 30) Pharmaceuticals

Regulation Type: Regular notification

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

The Ministry of Food and Drug Safety of the Republic of Korea is proposing to amend the “Designation of Self-quality Inspection Checklist and Details of Hygiene Products” as follows: Establishment of inspection item “oral care products” and “tattoo inks”The phthalate plasticizers (DINP, DIDP, DnOP, DIBP) are added to inspection item for “disposable cotton swab and diapers for young children” 

Products Covered: Cleansing and Hygiene products

Regulation Type: Regular notification

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

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

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

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

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

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