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RDC No. 589/2021

(Brazil) ANVISA Board of Directors Resolution No. 589, December 20, 2021

Update Date: Apr 9, 2025
Latest Published
Dec 22, 2021
Implemented
Jan 3, 2022
Abolished
Alternative Regulations
This resolution amended the following resolutions on December 22, 2021: (Brazil) Technical Regulation for Plastic Packaging and Equipment in Contact with Food (ANVISA Resolution No. 105 of May 19, 1999); (Brazil) MERCOSUR Technical Regulation on the Positive List of Monomers, Other Starting Substances, and Polymers Approved for the Manufacture of Plastic Packaging and Equipment in Contact with Food (RDC No. 56/2012); (Brazil) Technical Regulation for Cellulosic Materials, Packaging, and Equipment in Contact with Food (RDC No. 88/2016).
Industry
Chemical
Region
Brazil
Issuing Authority
Brazilian Health Regulatory Agency(ANVISA)
Main Content
This resolution revises the Board of Directors Resolution No. 105 of May 19, 1999; No. 56 of November 16, 2012; and No. 88 of June 29, 2016, including: Revision of the overall migration limit (OML) for plastic packaging and equipment as specified in Resolution No. 105 of 1999, clarifying migration limits under different conditions; Addition of item 12 in Resolution No. 56 of 2012, specifying that colored, printed plastic materials and polymer coatings must not migrate detectable amounts of aromatic amines (detection limit of 0.01 mg/kg); Update of the list of authorized monomers and other initiators in Resolution No. 56 of 2012, including new substances, revised limits, and specifications; Revision and supplementation of the provisions for cellulose materials and equipment in Resolution No. 88 of 2016, such as new restrictions and conditions on the use of specific chemicals. This resolution applies to plastic and cellulose material packaging and equipment in contact with food on the Brazilian market.
Operation
Translations
(Brazil) ANVISA Board of Directors Resolution No. 589, December 20, 2021
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