PCR-PET REGULATION

VISCONEWS ISSUE #08 · Jul 2017

In Mexico and in several countries of South America there are already operating plants that manufacture decontaminated food grade PCR-PET, and in other countries of the region, interesting industrial initiatives related to this material are being developed.

PROFESSOR ENGINEER ALEJANDRO ARIOSTI - National Institute of Industrial Technology (INTI) Plastics Centre Argentinia

In order to protect public health and food quality and sensory characteristics, the indiscriminate reuse of plastics FCMs is forbidden in general in several Latin American countries. However, there are legal exceptions to this prohibition. The sanitary authorities of these countries are working along with the R&D institutes, the standardization and certification institutions, and industry, in order to develop standards and/or regulations to ensure a rational and safe use of food contact PCR-PET.

For instance, since 2007, in the Common Market of the South (MERCOSUR in Spanish; MERCOSUL in Portuguese), the South American block, which member states are Argentina, Brazil, Paraguay, Uruguay, and Venezuela (with Bolivia in process of adhesion), Regulation 30/07 deals with PCR-PET for food contact. The main markets for the use of this material in mixtures with virgin PET are ISBM monolayer bottles for beverages and extruded cast sheets for thermoformed trays.

According to MERCOSUR Regulation 30/07, PCR-PET must be manufactured using only technologies that have a no-objection letter (NOL) issued by the US FDA or a favorable evaluation by the EU EFSA. That means that the technologies have been validated by a challenge test or modelization, according to the US FDA and EFSA protocols. There is a pre-market a pproval system for the operating facility and the validated technology it uses, the PCR-PET as raw material, and the final articles (bottles, trays, etc.), which is coordinated by the member states sanitary authorities. Traceability, application of GMPs, a quality management system, physical-chemical testing of input and output materials and their records, and sensory tests are required. The US FDA NOLs and EFSA´s favorable scientific opinions are recognized by MERCOSUR.

Besides, food contact articles manufactured with PCR-PET must comply with MERCOSUR Regulations 56/92 (general requirements for plastics), 02/12 (positive list of monomers and polymers), 32/07 (positive list of additives for plastics; under revision at present), 15/10 (pigments and colorants for plastics), and 32/10 (overall and specific migration evaluation).

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