• Resolution of the Collegiate Board (RDC) ANVISA No. 1,020, of April, 2026, establishing the sanitary requirements applicable to silicones used in materials, packaging, coatings, and equipment intended to come into contact with food. This resolution incorporates into the national legal system the GMC/MERCOSUR Resolution No. 34/2025. 
• Normative Instruction (IN) No. 435/2026 establishing the technical requirements for same product category. It acts in a complementary manner to Resolution of the Collegiate Board (RDC) No. 1,020/2026.

RDC No 1,020/2026：

It defines fundamental principles to guarantee the safety of silicones in contact with food. Silicone materials, packaging, coatings, and equipment must be manufactured in accordance with Good Manufacturing Practices and be compatible with food. It is prohibited for these materials to release undesirable or contaminating substances into food in quantities that could: modify the composition of the food; alter its sensory characteristics; or pose a risk to human health. Main topics:

• The substances used in the manufacture of silicones must meet criteria of purity and technical quality. The use of colorants is permitted, provided it complies with RDC No. 52/2010, or any standard that replaces it.
• Silicone material that come into contact with food cannot:
  • Release more than 0.5% of volatile organic material;
  • Release more than 0.5% of extractable compounds;
  • Testing positive for peroxides; and
  • Release primary aromatic amines in detectable quantities (detection limit of 0.01 mg/kg) in food or food simulants, when originating from colored silicone articles.
• For nipples of childcare products manufactured with elastomeric silicones, there are specific limits for the release of total N-nitrosamines (0.01 mg/kg) and total N-nitrosable substances (0.1 mg/kg) in a test performed according to the analytical methodology found in the UNE - EN 12868 standard "Method for determining the release of N-nitrosamines and N-nitrosatable substances from elastomer or rubber teats and soothers”
• The criteria and methodology for verifying compliance with the specific migration limits of silicone materials and articles are defined in the following standards, or others that may replace them: RDC No. 51/2010; and RDC No. 326/2019.

Normative Instruction (IN) No. 435/2026:

It sets the definitions, lists of authorized substances (positive list), composition limits and analytical methods to ensure the sanitary safety of silicone materials that come into contact with food. This includes everything from kitchen utensils to industrial seals and baby bottle nipples. The substances authorized for the manufacture of silicones are restricted to those provided for in IN 435/2026, observing the restrictions on use, specific migration limits, and composition limits established. Additionally, the use of additives authorized by RDC No. 778/2023 and IN No. 211/2023 is permitted, provided that the technological functions and maximum limits are observed, and that the sum of the amount of additive present in the food with the amount that may migrate from the packaging does not exceed the established maximum limits. Main topics:

• Specific Migration Limit for the following elements:
  • Aluminum = 1 mg/kg;
  • Barium = 1 mg/kg;
  • Cobalt = 0.05 mg/kg;
  • Copper = 5 mg/kg;
  • Iron = 48 mg/kg;
  • Lithium = 0.6 mg/kg;
  • Manganese = 0.6 mg/kg;
  • Nickel = 0.02 mg/kg;
  • Zinc = 5 mg/kg.
• Analytical methodology:
  • The methods for extracting metals and metalloids must follow the procedures defined in Resolution AP(89)1 of the Council of Europe, Committee of Ministers, concerning the use of colorants in plastic materials intended to come into contact with food, section III, paragraph 2.
  • For filtration procedures, the DIN 53770-1 standard - Pigments and fillers - Determination of hydrochloric acid-soluble matter, Part 1, item 3 (Apparatus), of the German Institute for Standardization (Deutsches Institut für Normung - DIN) must be used.
  • The determination of the metal and metalloid content in the extracts must be carried out by spectrometric quantification techniques with adequate sensitivity to verify compliance with the established limits.
  • Method for determining the release of free volatile organic matter, extractable compounds and peroxide residue in silicone elastomers described in the Normative Instruction
• Positive lists and restrictions:
  it may be modified to include new components, alter restrictions, or exclude components, based on new technical-scientific knowledge and technological justification. References for these modifications include:
  • Positive lists of normative acts of the European Union;
  • Recommendations from the German Federal Institute for Risk Assessment (BfR);
  • Lists of authorized substances from the United States Food and Drug Administration (FDA); and
  • Other recognized legislation and recommendations, exceptionally.

RDC No 1,020/2026 and Normative Instruction No. 435/2026 entered into force immediately.

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