Mercosur Updates Technical Regulation for Food Contact Silicone Materials

SafeGuardSHardgoodsJanuary 13, 2026

SG 005/26

Mercosur revises resolutions associated with food contact silicone materials and articles.

In December 2025, the Southern Common Market (Mercado Común del Sur, Mercosur) announced the approval of Mercosur/GMC/Res. No 34/2025 ‘Mercosur Technical Regulation on Silicones for the Manufacture of Materials, Packaging, Coatings and Equipment Intended to Come into Contact with Food’ (Modification of GMC Resolution Nos. 27/99 ‘Adhesives’, 28/99 ‘Positive list for elastomers’ and 02/12 ‘Positive list for plastics’).

Key highlights in Mercosur/GMC/Res. No 34/2025 are summarized in Table 1.

Annex to Mercosur/GMC/Res. No 34/2025	Highlights
2 ‘Scope’	Food contact silicones
3 ‘General provisions’	Authorizes manufacturers to use only the positive list of substances and their specifications in Parts I-V of the technical regulation Allows the use of dyes, but they must meet the requirements in Mercosur Technical Regulation on dyes in food contact plastics Permits the use of authorized food additives and their specifications in Mercosur technical regulations that are not indicated in this technical regulation Emphasizes that the positive list does not include ‘non-intentionally added substances (NIAS)’ in the finished good Allows the use of salts (including double salts and acid salts) of ammonia, calcium, magnesium, potassium and sodium of authorized acids, phenols or alcohols as additives Approves the use of salts (including double salts and acid salts) of nine metals of authorized acids, phenols or alcohols as additives, but they must meet the following Total Specific Migration Limits (SML (T)): ≤ 1 mg/kg each of aluminum (Al) and barium (Ba) ≤ 0.05 mg/kg cobalt (Co) ≤ 5 mg/kg each of copper (Cu) and zinc (Zn) ≤ 48 mg/kg iron (Fe) ≤ 0.6 mg/kg each of lithium (Li) and manganese (Mn) ≤ 0.02 mg/kg nickel (Ni) Stresses that the criteria and methodology for verifying compliance with the SMLs are in the Mercosur technical regulations on migration in food contact plastics and food contact plastic additives ≤ 0.5% volatile organic matter (VOM) using the specified method in the Technical Regulation ≤ 0.5% extractable compounds using the defined method in the Technical Regulation Requires ‘negative’ for peroxides using the method as described in the Technical Regulation ≤ 0.01 mg/kg sum of primary aromatic amines (PAA)
4 ‘Positive list’	Provides several terms with abbreviations and their definitions Contains five parts, each with its positive list and specifications: Part I ‘Silicone oils (fluids) and their respective emulsions’ Part II ‘Silicone resins’ Part III ‘Elastomeric silicones (silicone rubber)’, including the use of UNE EN 12868 for the following: ≤ 0.01 mg/kg sum of N-nitrosamines (elastomeric silicone nipples) ≤ 0.1 mg/kg sum of N-nitrosatable substances (elastomeric silicone nipples) Part IV ‘Additives, Fillers and Filler Additives’, including the use of the specified standards for purity requirements in fillers: ≤ 0.005% antimony (Sb) ≤ 0.01% for each of arsenic (As), cadmium (Cd) and lead (Pb) ≤ 0.0005% mercury (Hg) Part V ‘Monomers’

Table 1

Member states (Argentina, Brazil, Paraguay and Uruguay) are required to transpose this resolution into their national legislation before June 16, 2026.

Bolivia became a full member of Mercosur in 2024 (Law 1567 of July 4, 2024) and has a four-year transition period to align its legislation with Mercosur guidelines.

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