Mercosur’s Updated Additives Positive List Discussed at KH Seminar
The Mercosur Technical Regulations on Positive List of Additives for Plastic Materials and Polymeric Coatings Intended to Contact Food (GMC Res. 39/19) was adopted on July 15, 2019, after a 6-year revision process. This regulation must be transposed into Mercosur Member States’ laws to become effective and replace GMC Res. 32/07. This process could take up to a year, explained Associate Kathryn Skaggs at Keller and Heckman’s 20th Annual Food Packaging Law Seminar, held September 24-25, 2019, in Arlington, Virginia.
The technical regulation applies to additives and adjuvants of polymerization to be used in plastic materials and polymeric coatings in direct contact with food, said Ms. Skaggs. It includes the following definitions:
- Additive: Intentionally added to formulation of the material to obtain a physical or chemical effect during the manufacture of the plastic or in the material or final object
- Adjuvant/Polymerization aid: Used to provide a medium suitable for the manufacture of a polymer, plastic, or a polymeric coating; may be present but is neither intended to be present in the final article nor to have a physical or chemical effect on the plastic or final article
The positive list excludes solvents provided they have a boiling point less than 150℃; are not carcinogens, mutagens, or reproductive toxins; and do not migrate to food at levels greater than 0.01 mg/kg (10 ppb), explained Ms. Skaggs. The list also excludes initiating catalyst systems, accelerators, catalysts, modifiers and catalyst deactivators, molecular mass regulators, and REDOX agents, in addition to NIAS (impurities of substances used, intermediate reaction products, and decomposition products).
The regulation provides in Table 1 the positive list of additives along with use restrictions and specifications, such as specific migration limits (LME) and whether a fat reduction factor is applicable. GMC Res. 39/19 further permits the use in food-contact plastics of food additives authorized under other Mercosur Technical Regulations, provided: restrictions established for food use are met and the amount of additive in plastic packaging material does not migrate at levels that will exceed established limits on additive for food use. The positive list also includes salts (double salts and acid salts) of metals, phenols, or alcohols; however, LMEs apply to certain metals, noted Ms. Skaggs.