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Brazil releases new regulations on silicone materials and products for food contact

Time：

2026-04-27

Brazil has officially released new regulations on silicone materials and products used in food contact, which will come into effect on April 7, 2026.

On April 7, 2026, the Brazilian National Health Supervision Agency passed Resolution 1020/2026, officially adopting and issuing new regulations on silicone materials and products used in food contact, incorporating Resolution 34/25 of the Southern Common Market/GMC/RES into Brazilian domestic law.

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Regulatory content

The key provisions of the regulations for silicone materials and products in contact with food include:

Authorize the use of IN No. 435/2026, an interconnected document that establishes definitions, seven authorized substance lists for the manufacture of food contact silicone rubber materials and products, and an appendix for the determination of three chemical substances：

Appendix I "Substances that can be used for silicone oil or fluids and their corresponding lotion"

Appendix II "Substances that can be used to manufacture silicone resin"

Appendix III "Substances that can be used to manufacture silicone elastomers or silicone rubber"

Appendix IV "Substances Used for Manufacturing Silicon Coatings"

Appendix V "Authorized Substances for Manufacturing Children's Articles"

Appendix VI "Substances that can be used as additives, fillers, and filler additives"

Attachment 7 "Substances that can be used as monomers"

Attachment 8 "Methods for Determining Volatile Organic Compounds (VOCs), Extractable Compounds, and Peroxide Residues in Silicone Rubber"

Require manufacturers or importers to provide product ingredient information to the competent health department when requested

Call for the use of two criteria to verify compliance with specific migration limits (SMLs)：

RDC Resolution 51/2010 "Migration of plastics in contact with food"

RDC Resolution 326/2019 "Positive List for Production of Food Contact Plastics and Polymer Coatings"

Instruct to use the method described in Annex 8 of IN No 435/2026 to test three chemicals：

≤ 0.5% volatile organic compounds

≤ 0.5% extractable compound

Peroxide negative

Set the total limit of primary aromatic amines (PAA) to 0.01 mg/kg

Introduce specific migration requirements for elastic silicone pacifiers in child care products, using UNE EN 12868：

≤ 0.01 mg/kg total N-nitrosamines

≤ 0.1 mg/kg total precursor of N-nitroso compounds

Abolish several provisions in Annex I of Resolution RDC No. 123/2001, including the "List of Positive Surfaces for Food Contact Elastic Packaging and Equipment," as well as the authorized list of silicone polymers under Part 5 of Resolution RDC No. 56/2012

The new regulations will come into effect on April 7, 2026 and will affect stakeholders in the supply chain of food contact silicone materials and products, including manufacturers, importers, distributors, and retailers.

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