Regulatory Updates

Distribution date: 22 September 2025

Proposal of maximum residue limits (MRLs) for the following agricultural chemical:Pesticide: Polyoxorim-zinc.

Products Covered: Natural honey (HS code: 04.09)Edible vegetables and certain roots and tubers (HS codes: 07.02, 07.03, 07.04, 07.05, 07.07, 07.09 and 07.10)Edible fruit (HS codes: 08.07, 08.08 and 08.11)Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS code: 12.12)

Regulation Type: Regular notification

Distribution date: 22 September 2025 | Final date for Comment: 21 November 2025

Proposal of maximum residue limits (MRLs) for the following agricultural chemical:Pesticide: Picarbutrazox.

Products Covered: Natural honey (HS code: 04.09)Edible vegetables and certain roots and tubers (HS codes: 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.09, 07.10 and 07.14)Edible fruit and peel of citrus fruit (HS codes: 08.04, 08.05, 08.07, 08.10, 08.11 and 08.14)Spices (HS codes: 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10)Cereals (HS code: 10.06)Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.07 and 12.12)

Regulation Type: Regular notification

Distribution date: 22 September 2025 | Final date for Comment: 21 November 2025

Proposal of maximum residue limits (MRLs) for the following agricultural chemical:Pesticide: Ethaboxam.

Products Covered: Natural honey (HS code: 04.09)Edible vegetables and certain roots and tubers (HS codes: 07.01, 07.02, 07.04, 07.05, 07.07 and 07.10)Edible fruit (HS codes: 08.06 and 08.11)

Regulation Type: Regular notification

Distribution date: 22 September 2025 | Final date for Comment: 21 November 2025

Proposal of maximum residue limits (MRLs) for the following agricultural chemical:Pesticide: Clofentezine.

Products Covered: ・ Meat and edible meat offal (HS codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09)・ Dairy produce, birds' eggs and natural honey (HS codes: 04.01, 04.07, 04.08 and 04.09)・ Animal originated products (HS code: 05.04)・ Edible vegetables and certain roots and tubers (HS codes: 07.02, 07.07, 07.09 and 07.10)・ Edible fruit and nuts, peel of citrus fruit (HS codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10,08.11 and 08.14)・ Tea and spices (HS codes: 09.02, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10)・ Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.07 and 12.10)・ Animal fats and oils (HS codes: 15.01, 15.02 and 15.06)

Regulation Type: Regular notification

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

This draft Commission Implementing Decision does not renew the approval of etofenprox for use in biocidal products of product-types 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 withdrew their applications for the renewal of approval of etofenprox for both product-types of 8 and 18. The draft Decision will therefore propose to not renew the approval of etofenprox for product-types 8 and 18. In order to allow sufficient time for economic operators to adapt, treated articles treated with or incorporating etofenprox for use in biocidal products of product-types 8 and 18 may be placed on the market for a period of 180 days after the entry into force of this Decision.

Products Covered: Biocidal products

Regulation Type: Regular notification

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

The notified draft resolution establishes the maximum values permitted for arsenic, lead, cadmium, mercury and tin in different categories of food. It sets out general and specific implementing criteria, it defines how the limits are determined for processed, frozen or composite products, and it includes tables with the maximum values by food type (cereals, meat, fish, dairy products, beverages, fruit, vegetables, etc.) It also repeals the previous regulations (GMC Resolutions No. 12/11 and No. 18/21).

Products Covered: Foods, including cereals, meat, fish, dairy products, beverages, fruit and vegetables.

Regulation Type: Regular notification

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