European Standards, packaging requirements

The main guidance on package requirements can be found in pharmacopoeias (Table 3.11). Of the three key pharmacopoeias of the world (USP/NF, Ph Eur and Japanese Pharmacopoeia), it is the European Pharmacopoeia that is the main reference source in the EU, being set up by the Convention of Elaboration of European Pharmacopoeia of the Council of Europe. Once a monograph is accepted, EU members are charged to make the monographs official standards in their own countries. However, this does not... 

EN 13432, Packaging Requirement for Packaging Recoverable through Composting and Biodegradation - Test Scheme and Evaluation Criteria for the Final Acceptance of Packaging, European Committee for Standardization, Brussels, 2000. 

The European standard DIN EN 13432 details the requirements in particular for recycling of packaging materials by composting and biodegradation. This standard provides test schemes and evaluation criteria for rating packaging. 

This European standard was conceived specifically for packaging materials and it defines requirements and methods to determine the compostability and anaerobic treatability of packaging materials. DIN EN 13432 has completely replaced the former German standard DIN V 54900 however, it is essentially based on the former standard. Other than in the German standard, DIN EN 13432 provides only a framework, i.e., it does not provide details on the specific procedures. The specific testing procedures and requirements are more or less identical. 

The European standard DIN EN 14995 also provides a framework for procedures that can be used to support requirements regarding the compostability of plastics. Unlike DIN EN 13432 it does not focus solely on packaging, but defines requirements for plastic materials in general in order to be classified as organically recyclable. 

DIN EN 13427 Packaging - Requirements for the use of European Standards in the field of packaging and packaging waste... 

European Standard EN 13432 (2000) Packaging - Requirements for packaging recoverable through composting and biodegradation - Test scheme and evaluation criteria for the final acceptance of packaging. 

Antioxidants should be labelled on the retail package with the specific chemical name or with the EC number. The legislation of member states of the EU is influenced by the decision taken within the EC. Some food standards are fully based on EC Directives and some are still based on national considerations. There may be differences between European states, for instance, the utilisation of ascorbic acid as antioxidant for egg products is permitted in France but prohibited in Germany. These differences concern usually the utilisation of antioxidants in various food commodities. The specification of antioxidants mentioned in EC Directives are respected by all member states. But it is still generally required that individual countries of the European Union as well as the central organisation should be approached. The requirements appearing in the EC Directives on additives must be applied by the member states. This means in the first place that for those categories of additives for which a Community positive list exists, member states may not authorise any additives which do not appear on the positive list. 

The European Commission has mandated the European Committee for Standardization to establish a validated method of analysis for the determination of OMLs and SMLs. If a product complies with the compositional requirements of the directives, i.e., it is produced from authorized monomers and additives, then it may be tested for any desired application. If it meets the migration requirements, it is acceptable for use in cases covered by that test method. Typical food simulants used in the tests are hot water, acetic acid, ethyl alcohol and olive oil. The choice of an appropriate simulant depends on the type of food expected to come into contact with the packaging. 

Beyond perfonnance optimization, issues relative to packaging and the need for compliance with certain safety and electronics regulatory codes are cited as reasons for a customized solution. In the latter case, a systems approach is required, especially when attempting to meet the code or performance requirements for compliance with European Certification (CE) mark or electrical and fire safety codes such as National Eire Prevention Association (NFPA) and CENELEC (European Committee for Electrotechiucal Standardization). Off-the-shelf electronics may provide the necessary performance characteristics for generic applications, and their use eliminates large expenses related to product development, plus the associated time delays. Photonics-related components are solely addressed in this section because they are used to customize instruments for application-specific systems. 

---