Brazil has established a positive list of additives for food contact plastics and polymeric coatings. The new Technical Regulation will become effective on June 1, 2020.
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:
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.
| 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 | ||
|---|---|---|
| Phthalate | Specific Migration Limit | Plasticized Material in Food Contact Plastics |
| BBP* | ≤ 30 mg/kg | ≤ 0.1% |
| DBP* | ≤ 0.3 mg/kg | ≤ 0.1% |
| DEHP* | ≤ 1.5 mg/kg | ≤ 0.1% |
| DIDP* | ≤ 9 mg/kg (sum of DIDP and DINP) | ≤ 0.1% |
| DINP* | ≤ 0.1% | |
| *≤ 60 mg/kg as part of a group restriction (total specific migration limit) | ||
Table 1. Highlights on the restriction of BBP, DBP, DEHP, DIDP and DINP
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