SAFEGUARDS | Consumer ProductsNO. 011/20
On December 4, 2019, the Brazilian National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) published 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) to establish a positive list of additives for food contact plastics and polymeric coatings. It does not include polymerization aids and non-intentionally added substances (NIAS), the latter include 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.
Transposed from Mercosur GCM Resolution No. 39/2019, the new Technical Regulation contains, inter alia, a number of important provisions:
- A positive list of more than 1,000 substances
- Restrictions for nine metals in authorized acids, phenols or alcohols:
- ≤ 1 mg/kg (aluminum, Al)
- ≤ 1 mg/kg (barium, Ba)
- ≤ 0.05 mg/kg (cobalt, Co)
- ≤ 5 mg/kg (copper, Cu)
- ≤ 48 mg/kg (Iron, Fe)
- ≤ 0.6 mg/kg (lithium, Li)
- ≤ 0.6 mg/kg (manganese, Mn)
- ≤ 0.02 mg/kg (nickel, Ni)
- ≤ 5 mg/kg (Zinc, Zn)
- Restrictions for five phthalates (see Table 1 below):
- Benzyl butyl phthalate (BBP, CAS 85-68-7)
- Dibutyl phthalate (DBP, CAS 84-74-2)
- Bis(2-ethylhexyl) phthalate (DEHP, CAS 117-81-7)
- Diisodecyl phthalate (DIDP, CAS 26761-40-0 and 68515-49-1)
- Diisononyl phthalate (DINP, CAS 28553-12-0 and 68515-48-0)
- Solvents with a boiling point of less than 150 °C not in Table 1 of the technical regulation are allowed to be used, providing these are not carcinogenic, mutagenic or reprotoxic substances (CMR substances) and each of their migration values is not greater than 0.01 mg/kg
- 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)
The specifications for regenerated cellulose and DINP (substance MCA# 727 and 728), and salts of cis-1,2-cyclohexanedicarboxylic acid (substance MCA# 816) were rectified in the Brazilian Official Gazette (Diário Oficial da União, DOU) of January 2, 2020.
The new Technical Regulation repeals Resolution RDC No. 17 of March 17, 2008 on food contact plastics, and will become effective on June 1, 2020 – 180 days after its publication in the DOU.
Highlights on the restriction of five phthalates (BBP, DBP, DEHP, DIDP and DINP) in the positive list of substances under RDC 326/2019 are summarized in Table 1.
Table 1. Highlights on the restriction of BBP, DBP, DEHP, DIDP and DINP
|Resolution RDC No. 326 of December 3, 2019
Establishes the Positive List of Additives Intended for the Manufacture of Plastic Materials and Polymeric Coatings Intended to Come into Contact with Food and Other Measures
Official Gazette of the Federal Government of Brazil, No. 234, December 4, 2019
||Specific Migration Limit
Plasticized Material in Food Contact Plastics
for Children 0-3 Years old
||≤ 30 mg/kg
|| ≤ 0.1%
||≤ 0.3 mg/kg
|| ≤ 0.1%
||≤ 1.5 mg/kg
|| ≤ 0.1%
||≤ 9 mg/kg
(sum of DINP and DNOP)
| ≤ 0.1%
|| ≤ 0.1%
|*≤ 60 mg/kg as part of a group restriction (total specific migration limit)
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