New Rules on Permitted Silicone Substances for Food‑Contact

On April 7, 2026, Brazil’s National Health Surveillance Agency (ANVISA) enacted Normative Instruction No. 435, issued pursuant to RDC No. 1,020 of April 2, 2026, to establish the substances permitted in the manufacture of silicones used in food contact materials, packaging, coatings, and equipment.

This new instruction provides a structured regulatory framework through six annexes:  

• Annex I lists authorized substances for silicone oils, fluids and emulsions.
• Annex II covers silicone resins.  
• Annex III sets composition limits that listed substances must meet in final products.  
• Annex IV specifies substances for silicone coatings.
• Annex V and Article 11 for childcare products such as bottle and breastfeeding nipples, specify that elastomeric silicones may only use permitted substances Annex VI defines permitted additives, fillers and filler additives, ensuring safety and regulatory compliance across silicone applications.

RDC No. 1,020 provides for the sanitary requirements applicable to silicones used in materials, packaging, coatings and equipment intended to come into contact with food.

RDC No. 1,020

Normative Instruction No. 435