Brasil Pack Trends 2020

BrasilPackTrends2020 219 safety & regulatory issues and a decision tree for toxicological testing. This guide has been the basis for studies related to nanoparticles embedded in package materials. The European Union, in 2011, published Regulation 10/2011 (European Commission, 2011) which stipulates in Article 9 section 2 that the substances in nano form can only be used if they have been expressly authorized, i.e., the authorization of use of nano substances must be carried out on a case by case basis. It also establishes in Article 14 that the functional barrier concept does not apply to nanoscale substances. Currently this Regulation has approved only three nanometric substances: SiO 2 (with size specification included), carbon black (with size specification included) and TiN (with size specification included). In 2012, the FDA published a Draft Guidance for Industry:Assessing theeffectsofSignificantManufacturing Process Changes, including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, including ingredients that are color additives (U.S. DEPARTMENT... 2012) which includes in item III-E issues related to nanotechnology. This document states that safety assessments of nanoscale substances should be based on relevant data related to the chemical and physical properties of the substance. It also considers that the extrapolation of results is not possible and that the assessment should be conducted on a case by case basis. Amajor focus for the characterization of nanoparticles is its definition. The FDA, in the above cited document, has not yet established an official definition of a regulatory standpoint. The European Union published this definition in Recommendation 2011/696/EU of 18 October 2011: “Nanomaterial means as a natural, incidental or manufactured material, containing particles in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number of particles distribution, one or more external dimensions are in the size range of 1nm - 100nm. In specific cases where warranted by concern for the environmental, health, safety or competitiveness threshold of 50%may be replace by a threshold between 1 and 50%”. This document also provides definitions for particles, agglomerations and aggregates. Other documents related to risk assessment and risk management of nanotechnology were published by FAO (LUETZOW, 2012) and ILSI Europe (COCKBURN; BRADFORD, 2012). Studies related to the characterization of nanomaterial, nanoparticle migration and risk assessment have been conducted, and some results related to the migration of silver nanoparticles were published by Bott et al. (2012 a, b) and Noonan et al. (2012) and TiN nanoparticles (BOTT; STORMER; WOLZ; FRANZ, 2012c). In Brazil and MERCOSUR there is still no specific legislation on the use of nanomaterial for food contact. Recycled Materials With increasing environmental awareness and issues related to sustainable development, recycling of package materials for food contact has become very important. Plasticmaterials, which have their origin in oil, have become the main focus of discussion and since the nineties many plastics recycling processes have been developed. Plastics for food contact are regulated by various laws and must comply with positive lists and migration tests and should not transmit toxic substances to foods and / or change the odor / taste of the food. Recycled materials must also comply with these regulations. However, due to the chemical nature of the plastics, it is possible that contaminants resulting from the first use of the package or container misuse by the consumer can remain in the material and migrate to the food product. Thus, processes that ensure the cleanliness of the material for potential contaminants have been developed, allowing post-consumer recycled materials to be used again for food contact. There are two different processes for recycling, chemical and mechanical recycling. In chemical recycling, the plastic is depolymerized to monomers or oligomers, which are purified, isolated and used in the polymerization of new materials. For this process, if the monomers meet the purity criteria set out in the legislation, they are approved for food contact. In mechanical recycling, post-consumer material is melted again and subjected to steps of washing and decontamination. To prove the efficiency of