Brazil’s health regulator, Anvisa, has issued a new technical rule setting out which substances may be used to produce silicone materials, packaging, coatings and equipment intended to come into contact with food.
Normative Instruction No. 435 of 2 April 2026 establishes authorised substance lists, composition limits, migration limits and analytical test methods for silicone-based food-contact materials. The measure applies under RDC No. 1,020 of the same date and entered into force upon publication in Brazil’s Official Gazette on 7 April 2026.
The rule covers several categories of silicone materials, including silicone oils and fluids, silicone greases and pastes, silicone resins, elastomeric silicones or silicone rubbers, silicone coatings, additives, fillers, filler additives and monomers. It is highly technical, but its practical purpose is clear: to define which substances can be used in food-contact silicones and under what safety conditions.
Anvisa sets specific requirements for different silicone types. Silicone oils must be produced from authorised organopolysiloxanes and meet a minimum kinematic viscosity of 100 mm²/s at 20°C. Silicone greases and pastes must comply with the requirements for silicone oils, while silicone resins and rubbers are subject to separate positive lists and restrictions.
The instruction gives particular attention to elastomeric silicones, commonly used in reusable food-contact articles such as moulds, seals, gaskets, tubing and food-processing equipment. These materials may be made from authorised organopolysiloxanes and other listed substances, but several residual substances and reaction products are subject to strict limits, including non-detectable migration limits in some cases.
Childcare products are also specifically addressed. Silicone materials used in bottle nipples and breastfeeding nipples may only be produced from authorised substances listed in the dedicated annex, including specified crosslinking agents, catalysts and inhibitors, each subject to relevant residual or composition limits.
The annexes form the core of the measure. They list authorised substances for silicone oils, resins, rubbers, coatings, childcare products, additives, fillers and monomers. They also establish testing methods for free volatile organic matter, extractable compounds and peroxide residues in silicone elastomers.
The rule also sets limits for metals and contaminants. For example, migration limits are established for aluminium, barium, cobalt, copper, iron, lithium, manganese, nickel and zinc. Contaminants in soluble fillers, including lead, arsenic, mercury, cadmium and antimony, are also restricted. Testing must follow specified procedures, including Council of Europe and DIN methods, with spectrometric techniques used where needed.
For companies, the new instruction means that compliance will depend not only on whether a substance appears on an authorised list, but also on whether it meets the applicable concentration limits, migration limits, intended-use restrictions and test requirements. Manufacturers, importers and suppliers of silicone food-contact products may need to review formulations, technical documentation, supplier declarations and laboratory data.
In practical terms, Anvisa’s new instruction gives Brazil a more detailed framework for controlling silicone materials used in contact with food. It strengthens chemical safety requirements, clarifies authorised substances and testing expectations, and creates a clearer compliance basis for silicone products used in food packaging, food-processing equipment and childcare applications.
