SG 054/26
Brazil publishes new law for silicone materials and articles for food contact.
On April 7, 2026, Brazil’s National Health Agency (Agência Nacional de Vigilância Sanitária, Anvisa) issued two documents in the Official Gazette of the Union (Diário Oficial da União, DOU) to establish new sanitary requirements for food contact silicone materials and articles:
- Resolution of the Collegiate Board of Directors RDC No. 1020 of April 2, 2026 (Resolução da Diretoria Colegiada (RDC) No. 1020, de 2 de Abril de 2026, Resolution No. 1020/2026), specifying the sanitary requirements for food contact silicones
- Normative Instruction No. 435 of April 2, 2026 (Instrução Normativa No. 435, de 2 de Abril de 2026, IN No. 435/2026), a legal document complementing the sanitary requirements in Resolution No. 1020/2026
Resolution No. 1020/2026 transposes Mercosur/GMC/RES. No. 34/25 into Brazil’s domestic law.
What does this regulation require?
Key provisions in Resolution No. 1020/2026 include:
- Authorizing the use of IN No. 435/2026, an inter-connected document establishing, inter alia, definitions, seven lists of authorized substances for the manufacture of food contact silicone materials and articles, and one annex for the determination of three chemicals:
- Annex I ‘Substances that can be used for silicone oils or fluids and their respective emulsions’
- Annex II ‘Substances that can be used for the manufacture of silicone resins’
- Annex III ‘Substances that can be used for the manufacture of silicone elastomers or silicone rubber
- Annex IV ‘Substances for the manufacture of silicone coatings’
- Annex V ‘Authorized substances for the manufacture of childcare items’
- Annex VI ‘Substances that can be used as additives, fillers and additives for fillers’
- Annex VII ‘Substances that can be used as monomers’
- Annex VIII ‘Methods for determining the release of volatile organic matter (VOC), extractable compounds and peroxide residue in silicone elastomers’
- Requiring manufacturers or importers to provide information on product composition to the competent health authority when requested
- Calling for the use of two standards to verify compliance with specific migration limits (SMLs):
- Directing the use of methods described in Annex VIII of IN No 435/2026 for testing three chemicals:
- ≤ 0.5% VOM
- ≤ 0.5% extractable compounds
- Negative for peroxides
- Setting a limit of 0.01 mg/kg for sum of primary aromatic amines (PAA)
- Introducing specific migration requirements for elastomeric silicone nipples in childcare articles using UNE EN 12868:
- ≤ 0.01 mg/kg sum of N-nitrosamines
- ≤ 0.1 mg/kg sum of N-nitrosatable substances
- Repealing several provisions in Annex I to Resolution RDC No. 123/2001 ‘Positive list for food contact elastomeric packaging and equipment’ and the authorized list of silicone polymers under Part 5 to Resolution RDC No. 56/2012
Who is impacted?
The new law affects stakeholders operating across the food contact silicone material and article supply chain, including manufacturers, importers, distributors and retailers.
When does it apply?
Resolution No. 1020/2026 became effective on April 7, 2026 – the day of its publication in the DOU.
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