Brasil Pack Trends 2020

BrasilPackTrends2020 216 safety & regulatory issues Regulation 1935/2004 is the basis of European Union legislation, and applies to all package materials for food contact and defines four basic requirements for these materials: 1. Shall not endanger human health. 2. Shall not bring about an unacceptable change in the composition of the food. 3. Shall not alter the taste, smell or texture of the food. 4. Shall be manufactured in accordance with good manufacturing practices. The basic principles for Good Manufacturing Practices (GMP) are detailed in Regulation (EC) No 2023/2006 and were enforced on 1 August 2008. GMP should be applied to all stages of production of packages and materials. It excludes production stages of the starting substances and raw materials. For example, for the production of a plastic material, GMP requirements apply to transformers and converters, including the printing process of the package up to the production of the final article (SCHAFER, 2010). Regulation 1935/2004 establishes labeling and a traceability system requirement for the material or package, as well as compliance declaration requirement. This statement should contain all product information necessary for the food industry to use packages according to the conditions set out. Each manufacturer must issue a declaration of compliance for the process under their responsibility. Regulation 1935/2004 sets out specific requirements for the authorization of substances for food contact (including the Positive List) and migration limits. The migration tests to verify compliance with the law follow the methods validated by the European Committee for Standardization (CEN). This regulation contains a list of materials for which specific legislation should be adopted. This list contains 17 different materials although specific laws have been drawn up for only some of them: • Plastics: Regulation No. 10/2011, Regulation 1282/2011, Regulation 1183/2012. • Restricting the use of bisphenol A in baby bottles: Regulation 321/2011. • Import Procedures for polyamide and melamine kitchenware from China and Hong Kong - Regulation 284/2011. • Active and Intelligent Packaging: Regulation 450/2008. • Recycled plastic materials for food contact: Regulation 282/2008. • Regenerated cellulose materials: Directive 2007/42/EC. • Ceramics: Directive 84/500/EEC. For materials for which the laws were not harmonized within the EU, national laws can be applied as well as the resolutions of the Council of Europe. European Union The Center for Food Safety and Applied Nutrition (CFSAN) of the FDA is responsible for food contact materials. Substances which have contact with food are defined by the Federal Food, Drug and Cosmetic Act (FDCA) as those intentionally used as a component of food packaging material and which in use has no technical effect on the food. If these substances migrate into food, they are considered a food additive and therefore should be subject to regulations for food additives (Food Additive Petition - FAP) or be allowed through Food Contact Notification (FCN). The regulations for food additives relevant to substances with food contact are found in Title 21 of the Code of Federal Regulation (CFR) in Parts 174-186 and are related to cellulosic materials, plastics, adhesives and coatings, manufacturing additives etc., while the FCN are listed on the FDA website. Substances United States of America