Brazil has established a positive list of additives for food contact plastics and polymeric coatings.
Published on December 4, 2019 by the Brazilian National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), Resolution of the Collegiate Board of Directors No. 326 of December 3, 2019 (Resolução de Diretoria Colegiada No. 326, de 3 de Dezembro de 2019, RDC 326/2019) establishes a positive list of additives for food contact plastics and polymeric coatings. It does not include:
- Polymerization aids
- Non-intentionally added substances (NIAS) - impurities, reaction intermediates and decomposed products (substances that are present in food contact materials and articles (FCMs) but are not added during the manufacturing process
The new Technical Regulation, transposed from Mercosur GCM Resolution No. 39/2019, contains several important provisions. These include:
- A positive list of more than 1,000 substances
- Restrictions for nine metals in authorized acids, phenols or alcohols:
- Aluminum (Al): ≤ 1 mg/kg
- Barium (Ba): ≤ 1 mg/kg
- Cobalt (Co): ≤ 0.05 mg/kg
- Copper (Cu): ≤ 5 mg/kg
- Iron (Fe): ≤ 48 mg/kg
- Lithium (Li): ≤ 0.6 mg/kg
- Manganese (Mn): ≤ 0.6 mg/kg
- Nickel (Ni): ≤ 0.02 mg/kg
- Zinc (Zn): ≤ 5 mg/kg
- Restrictions for five phthalates (specific migration limit):
- Benzyl butyl phthalate (BBP): ≤ 30 mg/kg
- Dibutyl phthalate (DBP): ≤ 0.3 mg/kg
- Bis(2-ethylhexyl) phthalate (DEHP) : ≤ 1.5 mg/kg
- Diisodecyl phthalate (DIDP) & Diisononyl phthalate (DINP): ≤ 9 mg/kg (total)
- Solvents with a boiling point of less than 150 °C not in Table 1 of the technical regulation can be used, providing they are not substances known to be carcinogenic, mutagenic or reprotoxic (CMR), and each of their migration values is not greater than 0.01 mg/kg
Stakeholders should also be aware that there is a
separate limit for the five phthalates when in plasticized materials for food
contact plastics used by children aged zero to three years old. In all cases
the limit is ≤ 0.1%.
Unless stated in Table 1 ‘Positive List of Additives’ of the technical regulation, the sum of primary aromatic amines (PAAs) must not be greater than 0.01 mg/kg in 3% acetic acid (simulant B)
It should also be noted, the specifications for
regenerated cellulose and DINP, and salts of cis-1,2-cyclohexanedicarboxylic
acid, were rectified in the Brazilian Official Gazette (Diário Oficial da
União, DOU) of January 2, 2020.
Brazil’s latest Technical Regulation for food contact plastics repeals Resolution RDC No. 17 of March 17, 2008. It will come into effect on June 1, 2020 - 180 days after it was published in the DOU.
SGS Food Contact Material Services
SGS’s technical experts have extensive experience of testing materials and articles in contact with food. They can ensure that your products meet the appropriate regulations for food contact materials and pave the way for compliance. SGS offers the full range of testing, including migration tests, along with expert advice on emerging regulations, compliance issues and documentation review. Learn more about SGS’s Food Contact Material Services.
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