The Brazilian National Health Surveillance Agency (ANVISA) has published Normative Instruction No. 435 (2 April 2026) under RDC No. 1,020/2026, establishing detailed regulatory requirements for silicones used in food contact materials, packaging, coatings, and equipment. The regulation defines approved silicone types such as oils, resins, and elastomers, and sets key safety parameters like minimum viscosity (?100 mm/s at 20C for silicone oils) to reduce migration risk. It also includes stricter controls for childcare products, limiting permitted crosslinking agents and fillers for items like bottle nipples.
The instruction imposes strict limits on chemical contaminants and metal migration, including very low thresholds for heavy metals such as lead, cadmium, arsenic, and mercury, along with specific migration limits for metals like nickel, copper, and iron. It also mandates standardized analytical testing methods under Annex VIII, including volatile residue testing, solvent extraction using food simulants, and peroxide residue analysis to ensure material safety. Additionally, it regulates additives like carbon black and inorganic fillers with purity and composition limits. The regulation came into force upon publication in April 2026, requiring manufacturers and importers to immediately align their testing and technical documentation for compliance.
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