The "Common Market of the South" (MERCOSUR), consisting of Brazil, Argentina, Uruguay, and Paraguay, has now published on its website the much anticipated new Resolution on the Positive List of Additives for Use in Plastic Food-Contact Materials and Polymeric Coatings for Food-Contact Materials. This Resolution, designated as GMC Resolution No 39/19, repeals and replaces GMC Resolution No 32/07. It was formally sanctioned by the Common Market Group (GMC), which is the executive body of MERCOSUR, on July 15, 2019. It has been 12 years since this Resolution was last updated in 2007.
The updated Resolution aligns more closely with the European Union's (EU) "Commission Regulation (EU) No. 10/2011 on plastics and articles intended to come into contact with food" (the EU Plastics Regulation) with respect to the requirements imposed on additives used in food-contact plastics. Like the EU Plastics Regulation, all additives that are used in the production of food-contact plastics and intended to be present and function in the finished plastic, must be included on the positive list, which now includes over 1000 substances. Further, substances in nanoform must specifically be listed. Unintentional impurities, akin to Non-Intentionally Added Substances (NIAS) in the EU, including intermediate reaction products and decomposition products, are not required to be included on the Positive List. Further, certain polymerization aids, including catalysts, initiators, accelerators, molecular mass regulators, and REDOX agents are not required to be listed.
The positive list does include certain solvents used in the manufacture of polymers; however, unlisted solvents having a boiling point of less than 150°C also may be used, provided that they are not mutagens, carcinogens, or reproductive toxicants, and further provided that they will not migrate to food at levels greater than 0.01 mg/kg (10 parts per billion (ppb)). In addition, food additives that are authorized for direct addition to food also may be used in the manufacture of food-contact plastics and polymeric coatings, as long as any restrictions established for the direct food use are met, and the total amount present in food as a result of the direct addition and the migration from the food-contact material does not exceed any limits established for food use. Moreover, like the EU, MERCOSUR's GMC Resolution No 39/19 permits the use of certain salts of listed acids, phenols, or alcohols.
GMC Resolution No 39/19 differs from the EU Plastics Regulation in some important ways. Namely, its scope applies not only to plastics; it also is mandatory for polymeric coatings for all types of food-contact materials, including paper and metal. There is no specific "functional barrier" provision in GMC Resolution No 39/19, though we understand that the authorities do not consider it applicable to coatings used solely on the non-food-contact side of food cans. Furthermore, there is no "Declaration of Compliance" requirement under GMC Resolution No 39/19; however, manufacturers or importers of materials intended to come into contact with food must provide the composition of the product to the Competent Health Authority and/or other responsible bodies upon request.
Finally, the Resolution must be incorporated into the national laws of Argentina, Brazil, Paraguay, and Uruguay by January 15, 2020.