Brasil Pack Trends 2020

BrasilPackTrends2020 212 safety & regulatory issues required to produce plastic, cellulosic and metallic packages coated and uncoated in addition to adhesives, print inks and so on. It is also known that components of the package, when in contact with food can migrate to the product, in a process of mass transfer known as migration. In order to avoid chemical contamination of food products, laws based on the principle that the packages should be inert were conceived. Positive lists of substances which can be used in the composition of materials for food contact have been established. The authorization for these substances to become part of the Positive Lists is based on risk assessment and management. The risk, irrespective of its origin, is the combination of the toxicity of the substance (hazard) and how much of the substance is consumed (exposure). Therefore, to ensure the safety of package materials, it is not only necessary to consider the toxicity of any migrant (risk assessment), but also how much of this substance is found in foods, present in the basic diet of the population (estimated consumption). Likewise, changing a migration limit or restriction of a substance already listed or approved or approval of a new substance (polymer or additive), new materials and new technologies, risk assessment should be performed. The legislation for food contact in the European Union is based on the hazard of the chemical substance and a very conservative estimate of exposure in order to establish the Positive Lists. When the substance is known it is submitted to toxicological tests in accordance with protocols of traditional assessment of toxicity, where ADI (acceptable daily intake) or TDI (tolerable daily intake) are determined. The requirement for toxicological studies is linked to the amount of the substance that may ultimately migrate to the food product; the higher the migration, the more rigorous and greater number of toxicological tests should be carried out (BARLOW, 2008). The consumers’ exposure to these substances is established assuming that 1 kg of food; packed in a container of 6 dm 2 is eaten every day during their lifetime and that food will always be packaged in the same package type and that migration of the substance of interest is always at the maximum concentration allowed. Based on these parameters, restrictions on the use and limits of composition and, especially, the specific migration limits (SML) for many of the substances on the Positive Lists are established. The legislation in force in the United States differs from the European principally in relation to toxicological tests required to establish the safety of the substance for food contact. Whereas the European Union considers that the level of migration determines the toxicological tests that should be conducted, in the United States, the level of exposure to the substance will dictate the tests to be performed. The Food and Drug Administration (FDA) estimates the likely exposure to the substance by combining the migration data with information relating to typical uses of the package containing the substance of interest. As such, the lower the consumer exposure to the substance the fewer toxicological tests are required and it can be more easily included on the list of permitted substances for food contact (OLDRING, 2010). The MERCOSUR legislation, and hence the Brazilian legislation, is based on the harmonized European legislation and therefore the limits in force are also conservative. The MERCOSUR legislation also includes some substances approved by the United States, and in such cases, includes limits set by the Food and Drug Administration (FDA). Exposure assessment is the key part of risk assessment of a substance and is defined by the Codex Alimentarius (CODEX. .., 1969) as a “qualitative and / or quantitative evaluation of the intake of physical, chemical or biological agents by means of food or other sources if relevant”. Currently there is no universally recognized approach to estimate the exposure of consumers to migrants from packaging material. Exposure is the sum of the concentrations of migrants in food versus the weight of food consumed. The exposure can be estimated in various ways and can be summarized as described in the document published by the International Life Sciences Institute,( 2007):