Brasil Pack Trends 2020

BrasilPackTrends2020 215 safety & regulatory issues With the creation of the Southern Common Market (MERCOSUR) consisting of Brazil, Argentina, Paraguay and Uruguay there was the need to harmonize national laws including those related to package materials for food contact. The process of harmonization was initiated in March 1992, coordinated by the Common Market Group (GMC), the executive body of MERCOSUR which has among its functions the approval of the GMC Resolutions, which are harmonized Supranational Laws for the countries involved. The harmonization of legislation on package materials for food contact is discussed in the Working Subgroup 3 (SGT-3) - Technical Regulations and Conformity Assessment of MERCOSUR within the Food Commission. At the time of the formation of the common market, Brazil and Argentina already had laws regarding food contact materials based on the Positive List, total migration tests and composition limits. In 1992 at the beginning of the harmonization process, it was agreed that the law common to all four countries should also follow this model. The first MERCOSUR Resolution concerning package materials comes from this time; Resolution GMC 03/92 - “General Criteria and Classification of Package Materials and Equipment in Contact with Food in Annex to this Resolution,” It is still in effect and published in Brazil as Resolution RDC No. 91, May 11, 2001 (BRAZIL, 2001). This resolution applies to all packages and equipment that come into direct contact with food during its production, processing, fractionation, storage, distribution, marketing and consumption and defines the criteria for a food contact material: in compliance with Positive Lists, total migration limits, specific migration limits, when established, and composition limits. It is required that the components used in the package should have purity suitable for the intended purpose (BRAZIL, 2001). Among the general criteria it is established that packages must be manufactured in accordance with Good Manufacturing Practices, should not cause unacceptable changes in food composition or in sensory characteristics and should not pose risks to human health. Annexed to this resolution is the classification of package materials, which are regulated by specific resolutions. Legislation for plastics, cellulose, metal, glass, regenerated cellulose, elastomers, adhesives and film- forming polymers are in force in Brazil and MERCOSUR. These laws follow the principle of the Positive List and migration tests and are based on international legislation for these materials (PADULA, 2010). To be valid in the member states of MERCOSUR, resolutions must be incorporated into national legislation. In Brazil, the National Agency of Sanitary Surveillance (ANVISA) of the Ministry of Health is responsible for the internalization of GMC Resolutions, which is done through the publication of Ordinances and Resolutions for each type of package material. In Argentina, the GMC Resolutions become Resolutions of the Ministry of Health and are incorporated into the Argentinian Food Code. In Uruguay and Paraguay, GMC Resolutions were published by the Ministry of Public Health and the Ministry of Public Health and Social Welfare, respectively (PADULA; CUERVO, 2004). The criteria for inclusion of new substances in the Positive Lists involves justification of the technological need for their use, and approval according to policies or regulations of the European Union and/or the U.S. Code of Federal Regulations. Exceptionally, other internationally recognized laws can be accepted, as is the case with German Recommendations for cellulosic materials. The exclusion of substances or modifications of specific migration limits or composition limits are based on new scientific and technological knowledge. The legislation also establishes the criteria and procedures to be followed for the total and specific migration tests to check they meet the limits set in the Positive List and total migration limits (BRAZIL, 2010a). Purity criteria are also established for pigments and colorants (BRAZIL, 2010b). New packaging systems or new technologies must also be approved by the competent authority, submitting the completed studies for review and approval within MERCOSUR. MERCOSUR and Brazil