SG 016/26
South Korea has initiated a two-month consultation over its proposed revision to the nation’s standards and specifications for food contact materials (FCMs) and articles.
In South Korea, food contact materials and articles are regulated by the Food Sanitation Act (the Act). Chapter 3 of the Act prohibits the presence or use of toxic/harmful chemicals in food contact utensils, containers and packages that could endanger human health. It also directs the Ministry of Food and Drug Safety (MFDS) to establish standards and specifications for these products.
On January 8, 2026, South Korea’s MFDS issued Notice No. 2026-008, announcing its intention to revise the nation’s ‘Standards and Specifications for Utensils, Containers and Packages’ (MFDS Notification Notice No. 2024-29, the Standard, available in Korean or unofficial English translation). The proposal establishes new standards and specifications for rubber products with a design and method of use similar to pacifiers, allowing for the separate management of rubber products intended for infants and young children.
Key highlights of Notice No. 2026-08 compared to the Standard are summarized in Tables 1 and 2.
| The Standard: Section III, Clause 3b ‘Residual specification’ | Notice No. 2026-008: The Standard, Section V, Clause 3b ‘Residual specification’ | |
| Lead | ≤ 100 mg/kg (rubber other than rubber nipples) ≤ 10 mg/kg (rubber nipples) | ≤ 100 mg/kg ≤ 10 mg/kg (rubber products for infants and toddlers) |
| Cadmium | ≤ 100 mg/kg (rubber other than rubber nipples) ≤ 10 mg/kg (rubber nipples) | ≤ 100 mg/kg ≤ 10 mg/kg (rubber products for infants and toddlers) |
| 2-mercaptoimidazoline | Not detected (rubber containing chlorine) | Not detected (rubber containing chlorine) |
| 1,3-butadiene | ≤ 1 mg/kg (rubber containing 50% or more of 1,3-butadiene in base polymer) | ≤ 1 mg/kg (rubber containing 50% or more of 1,3-butadiene in base polymer) |
Table 1
| The Standard: Section III, Clause 3c ‘Migrant specification’ | Notice No. 2026-008: The Standard, Section V, Clause 3c ‘Migration specification’ | |
| Lead | ≤ 1 mg/L | ≤ 1 mg/L |
| Overall migration | ≤ 60 mg/L (rubber) ≤ 40 mg/L (rubber nipples) | ≤ 60 mg/L ≤ 40 mg/L (rubber products for infants and toddlers) |
| Phenol | ≤ 5 mg/L | ≤ 5 mg/L |
| Formaldehyde | ≤ 4 mg/L | ≤ 4 mg/L |
| Zinc | ≤ 15 mg/L (rubber) ≤ 1 mg/L (rubber nipples) | ≤ 15 mg/L (rubber) ≤ 1 mg/L (rubber products for infants and toddlers) |
| Nitrosamines¹ | ≤ 0.01 mg/kg (rubber nipples) | ≤ 0.01 mg/kg (rubber products for infants and toddlers) |
| Nitrosatable substances² | ≤ 0.1 mg/kg (rubber nipples) | ≤ 0.1 mg/kg (rubber products for infants and toddlers) |
| ¹N-nitrosodimethylamine, N-nitrosodiethylamine, N-nitrosodi-n-propylamine, N-nitrosodi-n-butylamine, N-nitrosopiperidine, N-nitrosopyrrolidine, N-nitrosopyrrolidine, N-nitrosomorpholine ²Sum of nitrosamines in footnote 1 above | ||
Table 2
Additionally, the proposal modifies the requirement of no more than 0.5% volatile compounds content for rubber nipples to all rubber products intended for infants and toddlers.
According to Notice No. 2026-008, comments will be accepted until March 9, 2026, and the provisions will enter into force on the date of promulgation.
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