Brazil Consults Over Proposals for Food Contact Silicone Materials

SafeGuardSHardgoodsMarch 11, 2024

SG 43/24

Brazil has initiated a two-month consultation on two proposals to regulate food contact silicone materials and articles. Comments are being accepted until May 5, 2024.

In February 2024, Brazil’s National Health Agency (Agência Nacional de Vigilância Sanitária, Anvisa) issued two inter-related proposals for food contact silicone materials and articles.

Highlights of these two proposals are summarized in Table 1.

Public consultation document	Highlights
Public Consultation No. 1235 of February 26, 2024 ‘Proposal for Resolution from the Collegiate Directorate that provides for the sanitary requirements applicable to silicones used in materials, packaging, coatings and equipment intended to come into contact with food (PC No. 1235/2024)	Exempts coatings intended for cellulosic materials Permits the use of authorized substances in the Normative Instruction for the manufacture of food contact silicone materials, subject to respecting the specifications therein (see PC No. 1236/2024 below) Allows the use of colorants provided these meet the requirements under Resolution RDC No. 52 of November 26, 2010 (or its replacement) for colors in packaging and plastic equipment intended to come into contact with food Details two requirements for silicone materials and articles: Silicone materials and articles: ≤ 0.5% volatile organic matter (VOM) ≤ 0.5% extractable compounds Negative for peroxides ≤ 0.01 mg/kg sum of primary aromatic amines (PAA) Silicone materials for childcare items ≤ 0.01 mg/kg N-nitrosamines and ≤ 0.1 mg/kg N-nitrosatable substances from saliva (UNE EN 12868)
Public Consultation No. 1236 of February 26, 2024 ‘Proposal for Normative Instruction that establishes the lists of substances that can be used in the manufacture of silicones used in materials, packaging, coatings and equipment intended to come into contact with food (PC No. 1236/2024)	Establishes specific migration limits (SML) for nine elements and their salts: ≤ 1 mg/kg for each of aluminum (Al) and barium (Ba) ≤ 0.05 mg/kg cobalt (Co) ≤ 5.0 mg/kg for each of copper (Cu) and zinc (Zn) ≤ 48 mg/kg iron (Fe) ≤ 0.6 mg/kg for each of lithium (Li) and manganese (Mn) ≤ 0.02 mg/kg nickel (Ni) Contains seven annexes detailing the use of substances, their specifications and methodologies: 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 (silicone rubber) Annex IV ‘Authorized substances for the manufacture of childcare items’ Annex V ‘Substances that can be used as additives, fillers and additives for fillers’ Annex VI ‘Substances that can be used as monomers’ Annex VII ‘Methods for the determination VOM release, extractable compounds and peroxide residue in silicone elastomers’

Public consultation document

Highlights

Public Consultation No. 1235 of February 26, 2024 ‘Proposal for Resolution from the Collegiate Directorate that provides for the sanitary requirements applicable to silicones used in materials, packaging, coatings and equipment intended to come into contact with food (PC No. 1235/2024)

Exempts coatings intended for cellulosic materials
Permits the use of authorized substances in the Normative Instruction for the manufacture of food contact silicone materials, subject to respecting the specifications therein (see PC No. 1236/2024 below)
Allows the use of colorants provided these meet the requirements under Resolution RDC No. 52 of November 26, 2010 (or its replacement) for colors in packaging and plastic equipment intended to come into contact with food
Details two requirements for silicone materials and articles:

Silicone materials and articles:

≤ 0.5% volatile organic matter (VOM)
≤ 0.5% extractable compounds
Negative for peroxides
≤ 0.01 mg/kg sum of primary aromatic amines (PAA)

Silicone materials for childcare items

≤ 0.01 mg/kg N-nitrosamines and ≤ 0.1 mg/kg N-nitrosatable substances from saliva (UNE EN 12868)

Public Consultation No. 1236 of February 26, 2024 ‘Proposal for Normative Instruction that establishes the lists of substances that can be used in the manufacture of silicones used in materials, packaging, coatings and equipment intended to come into contact with food (PC No. 1236/2024)

Establishes specific migration limits (SML) for nine elements and their salts:

≤ 1 mg/kg for each of aluminum (Al) and barium (Ba)
≤ 0.05 mg/kg cobalt (Co)
≤ 5.0 mg/kg for each of copper (Cu) and zinc (Zn)
≤ 48 mg/kg iron (Fe)
≤ 0.6 mg/kg for each of lithium (Li) and manganese (Mn)
≤ 0.02 mg/kg nickel (Ni)

Contains seven annexes detailing the use of substances, their specifications and methodologies:

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 (silicone rubber)
Annex IV ‘Authorized substances for the manufacture of childcare items’
Annex V ‘Substances that can be used as additives, fillers and additives for fillers’
Annex VI ‘Substances that can be used as monomers’
Annex VII ‘Methods for the determination VOM release, extractable compounds and peroxide residue in silicone elastomers’

Table 1

Comments for both PC Nos. 1235/2024 and 1236/2024 will be accepted until May 5, 2024.

SGS technical experts have extensive knowledge and testing experience in materials and articles in contact with food. They work to ensure that your products meet the appropriate regulations for food contact materials, paving the way for compliance. From overall migration tests to expert advice on emerging regulations, compliance issues and documentation review, SGS is the partner to trust. Discover more on our website. In the end, it’s only trusted because it’s tested.

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