Brasil Pack Trends 2020
BrasilPackTrends2020 218 safety & regulatory issues For active packages that interact with the foodstuff or the atmosphere around the product two situations can occur: the absorption of substances released by food (such as ethylene absorbers) or the emission of substances (such as antioxidants) that act on food improving its quality or condition. In this case, these substances are added to packaging to intentionally migrate into the food. However, the release of these substances into the food should be performed under certain conditions. The substance emitted must be authorized by food legislation and used in accordance with the requirements, i.e., the limits established must be observed independently of the origin of the substance in food (directly added or via the package) and be used only for permitted foods. The declaration of compliance of the packaging is essential in this case to ensure that consumers are properly informed by the food manufacturer, and also because this substance should be declared among the food ingredients on the label. For substances which have an active or intelligent function in the package, but should not intentionally migrate to food and have no function on the food, safety evaluation studies should be performed and then submitted to the opinion of the European Food Safety Authority (EFSA). When authorized these substances will be listed on a specific Positive List of active and intelligent packages and their identity, function and conditions and / or restrictions of use will be described. It is also important to remember that the materials in which the active ingredients are incorporated must comply with specific legislation for that material, for example, plastic material must meet the regulations for plastics. In Brazil, nowadays, the use of active and intelligent packages is restricted to substances described in the Positive List of packaging materials legislation, which are restricted to those that should not intentionally migrate to food and to those substances related in food laws that will be released and be part of the food. There is no current requirement to declare the ingredient on the food label and also no requirement of declaration of compliance issued by the package manufacturer. It is expected that in the near future these materials will be regulated in Brazil and MERCOSUR. Nanotechnology The safety of nanomaterial for food contact raises many questions: • Does the nanoparticle have potential for migration? • If so, what is the potential for ingestion of toxic, carcinogenic or teratogenic substances? • What are the biological interactions associated with the presence of the nanoparticle? What is important? Surface area? Mass? Surface modification with fillers, for instance? • What is the biological response to the presence of nanoscale materials ? • Do “traditional” toxicology risk studies apply to nanomaterial? • How is the consumers exposure to nanoscale materials characterized? • How are hazards identified and risks evaluated? • Are analytical techniques available to detect these materials effective? • How are materials with nanometer dimensions characterized? What equipment should be used? • How are environmental and occupational questions relating to nanomaterial answered? Currently not all questions have answers and there is still no specific packaging legislation for these materials. However, in recent years many advances have been observed in studies on the use of nanoparticles in package materials. In 2011, the European Food Safety Authority (EFSA) published a guide containing procedures for risk assessment of nanomaterial - Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain (GUIDANCE..., 2011). This guide covers the requirements for physicochemical characterization of nanomaterial and tests to identify and characterize hazards (in vitro genotoxicity, absorption, distribution, metabolism and excretion (elimination) - ADME and oral toxicity studies), which have their origin in nanoparticle properties such as size, surface area, reactivity, ability to ‘permeate’ through biological membranes and so on . The guide also presents schemes for risk assessment, toxicological evaluation
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