News Brief
Recently, the Ministry of Food and Drug Safety (MFDS) of South Korea issued Announcement No. 2026-008 and Announcement No. 2026-009, proposing amendments to the Standards and Specifications for Utensils, Containers, and Packages (No. 2024-29). The proposed changes are as follows:
Change 1: Introduction of Standards for Infant Rubber Products
The proposed amendments establish standards and specifications for infant rubber products (including rubber teething toys, rubber straws, etc.) to facilitate the independent regulation of these products. These items are required to meet the same high-level specifications as infant rubber pacifiers, including:
Residue Specification
Items | Specifications |
Lead | ≤10 mg/kg |
Cadmium | ≤10 mg/kg |
2-Mercaptoimidazoline | not detected (applied only to the rubber containing chlorine) |
1,3-butadiene | ≤1 mg/kg (applied only to the rubber material that contain 50% or more of 1,3-butadiene in base polymer) |
Migrant Specification
Items | Specifications |
Lead | ≤1 mg/L |
Overall migration | ≤40 mg/L |
Phenol | ≤5 mg/L |
Formaldehyde | ≤4 mg/L |
Zinc | ≤1 mg/L |
N-Nitrosam ines (sum of N-nitrosodimethylamine, N-nitrosodiethylamine, N-nitrosodi-n-propylamine, N-nitrosodi-n-buthylamine, N-nitroso-piperidine, N-nitroso-pyrrolidine, N-nitroso morpholine) | |
N-Nitrosatable substances (sum of N-nitrosodimethyl- amine, N-nitrosodiethylamine, N-nitrosodi-n-propylamine, N-nitrosodi-n-buthylamine, N-nitroso-piperidine, N-nitroso-pyrrolidine, N-nitroso morpholine) | ≤0.1 mg/kg |
Additionally, a new Total Volatile Matter Index has been introduced, requiring that the total volatile content of infant rubber products must not exceed 0.5%.
Change 2: Introduction of Recognition Standards for Physically Recycled Polypropylene (PP)
The proposed amendments expand the range of permissible physically recycled materials by adding physically recycled PP to the previously approved physically recycled PET materials. To ensure the safety of recycled materials, MFDS has clarified the requirements for closed-loop regulation:
Raw Material Admission Requirements: Raw materials must be composed of single PP material and must be recycled within a controlled closed-loop system to prevent non-food contamination. Furthermore, adhesives or direct printing (except for approved special ink) are prohibited on the container body, and the materials must undergo thorough cleaning with legally approved detergents.
Recycling Process Control: The recycling process must be independently managed to ensure compliance with critical operating parameters, including temperature and pressure, to guarantee safety and quality stability. Companies are required to establish Standard Operating Procedures (SOPs) in accordance with the proposed standards and submit validated testing methods as part of the scientific safety evidence documentation.
Recognition Application Documentation: Applications must be accompanied by test reports issued by accredited institutions, specifying the product's specific use, intended usage temperature, and types of food contacted. Additionally, comprehensive supply chain details, production process documentation, and quality assurance system evidence must be submitted.
Change 3: Revision of Migration Limit Requirements for DEHP and DEHA in PVC Materials
The original standards prohibited the inclusion of di-(2-ethylhexyl) phthalate (DEHP) in the manufacture of utensils, containers and packages, and di-(2-ethylhexyl) adipate (DEHA) in the production of cling wraps, except there is no possibility that DEHP and DEHA migrates into foods.
However, the migration limit requirements for DEHP and DEHA in PVC materials did not align with this prohibition. Therefore, the migration limit requirements for DEHP and DEHA in PVC materials have been revised as follows:
Items | Original migration limit | Revised migration limits |
Di-(2-ethylhexyl) phthalate (DEHP) | ≤1.5 mg/L | not detected |
Di-(2-ethylhexyl) adipate (DEHA) | ≤18 mg/L | ≤18 mg/L (But it must not be detected in cling wraps) |
Recommendations for Enterprises
The draft amendment is currently in the public consultation phase, as per the regulatory process, with a deadline for feedback submissions set for March 9, 2026. Relevant enterprises should submit their opinions before this date.
Meanwhile, regarding the newly introduced standards for infant rubber products and the adjustments to the migration limits for DEHP and DEHA in PVC materials, REACH24H recommends that relevant enterprises take proactive measures to ensure their products comply with the revised safety standards. For companies intending to apply for recognition of physically recycled PP, it is advised to develop a closed-loop recycling system and enhance Standard Operating Procedures (SOPs) and process validation documentation to meet the recognition requirements.
For more information or assistance, please feel free to contact us at customer@reach24h.com.
