Legislative issues relating to active and intelligent packaging N. de Kruif and R. Rijk, TNO Nutrition and Food Research, The Netherlands 22.1 Introduction Major technological developments in food packaging can introduce many benefits to consumers and food and food-packaging industries, but at the same time they are liable to the introduction of new problems. Although active and intelligent packaging continues to broaden in scope and these new packaging systems are already being successfully applied in the USA, Japan and Australia, its penetration in the European marketplace has been quite limited thus far. This is partly due to the strict European regulations for food contact materials, which fail to keep up with technological innovations and currently prohibit the application of many of these systems. In addition, a lack of knowledge of consumer acceptance, of economic aspects and of the environmental impact of these novel concepts and, in particular, the lack of hard evidence of their effectiveness demonstrated by independent investigators has inhibited their commercial usage Within the Actipak project active and intelligent packaging systems were defined as follows Active packaging actively changes the condition of the packaged food to extend shelf-life or improve food safety or sensory properties while maintaining the quality of the packaged food Intelligent packaging systems monitor the condition of packaged foods to give information about the quality of the packaged food during transport and storage In Europe, no specific regulation governing active and intelligent food packaging exists to date. Most active and intelligent agents are not considered
22.1 Introduction Major technological developments in food packaging can introduce many benefits to consumers and food and food-packaging industries, but at the same time they are liable to the introduction of new problems. Although active and intelligent packaging continues to broaden in scope and these new packaging systems are already being successfully applied in the USA, Japan and Australia, its penetration in the European marketplace has been quite limited thus far. This is partly due to the strict European regulations for food contact materials, which fail to keep up with technological innovations and currently prohibit the application of many of these systems. In addition, a lack of knowledge of consumer acceptance, of economic aspects and of the environmental impact of these novel concepts and, in particular, the lack of hard evidence of their effectiveness demonstrated by independent investigators has inhibited their commercial usage. Within the Actipak project active and intelligent packaging systems were defined as follows:1 • Active packaging actively changes the condition of the packaged food to extend shelf-life or improve food safety or sensory properties while maintaining the quality of the packaged food. • Intelligent packaging systems monitor the condition of packaged foods to give information about the quality of the packaged food during transport and storage. In Europe, no specific regulation governing active and intelligent food packaging exists to date. Most active and intelligent agents are not considered 22 Legislative issues relating to active and intelligent packaging N. de Kruijf and R. Rijk, TNO Nutrition and Food Research, The Netherlands
460 Novel food packaging techniques as food additives but rather as food contact material constituents and therefore these food packaging systems should comply with the existing regulations for food contact materials. When these regulations were drafted, no allowance was made for active and intelligent packaging as these systems were not applied as food contact materials in Europe at that time. The current packaging regulations require that all components used for the manufacture of food contact materials are covered by so-called positive lists. These lists of approved compound usually include components required to manufacture the packaging material Constituents used for other purposes such as extending or monitoring the shelf- life of packaged foods are not included. Therefore, most active and intelligent agents are not listed. In addition, active and intelligent systems should comply with relevant overall and specific migration limits. The overall migration limit of 60 mg per kg food is a major hurdle to the application of active packaging in Europe, especially when the system is designed to release active ingredients into foods to extend their shelf-life or improve their quality. Moreover,current migration tests are not always suitable for these new packaging systems because the conventional ratio of 6 dm- to l kg food is generally much smaller and, in addition, they often differ in contact mode from conventional packaging Therefore, a new approach to food packaging regulations is required, and new migration test methods should be developed and validated for some of these new food packaging systems No single European regulation currently covers specifically the use of active and intelligent packaging systems. The food-contact application of active and ntelligent packaging systems is covered by a range of EU regulations, each having its specific requirements, such as regulations for food-contact materials, food additives, biocides, modified-atmosphere packaging, hygiene of foodstuffs labelling and packaging waste. Some of these regulations may be unintentionally, an obstacle to the introduction of active and intelligent systems in Europe. Therefore, a few years ago, two initiatives were taken to implement active and intelligent packaging within the European regulations In 1999, a pan-European project was started within the framework of the EU FAIR R&d programme. The study aims at initiating amendments to European legislation for food contact materials to establish and implement active and intelligent systems within the current relevant regulations for packaged food in Europe,2 In 2000, a comprehensive report on legislative aspects of active and intelligent food packaging was published by a project group under the nordic Council of Ministers. The report describes some types of active and intelligent food contact materials, the legislation the project found to be relevant to consider, as well as some conclusions and proposals for administrators for future work with recommendations and interpretations of existing legislation. Also, the packaging is considered. Both initiatives will now be discussed in more detail
as food additives but rather as food contact material constituents, and therefore these food packaging systems should comply with the existing regulations for food contact materials. When these regulations were drafted, no allowance was made for active and intelligent packaging as these systems were not applied as food contact materials in Europe at that time. The current packaging regulations require that all components used for the manufacture of food contact materials are covered by so-called positive lists. These lists of approved compounds usually include components required to manufacture the packaging material. Constituents used for other purposes such as extending or monitoring the shelflife of packaged foods are not included. Therefore, most active and intelligent agents are not listed. In addition, active and intelligent systems should comply with relevant overall and specific migration limits. The overall migration limit of 60 mg per kg food is a major hurdle to the application of active packaging in Europe, especially when the system is designed to release active ingredients into foods to extend their shelf-life or improve their quality. Moreover, current migration tests are not always suitable for these new packaging systems because the conventional ratio of 6 dm2 to 1 kg food is generally much smaller and, in addition, they often differ in contact mode from conventional packaging. Therefore, a new approach to food packaging regulations is required, and new migration test methods should be developed and validated for some of these new food packaging systems. No single European regulation currently covers specifically the use of active and intelligent packaging systems. The food-contact application of active and intelligent packaging systems is covered by a range of EU regulations, each having its specific requirements, such as regulations for food-contact materials, food additives, biocides, modified-atmosphere packaging, hygiene of foodstuffs, labelling and packaging waste. Some of these regulations may be, unintentionally, an obstacle to the introduction of active and intelligent systems in Europe. Therefore, a few years ago, two initiatives were taken to implement active and intelligent packaging within the European regulations. In 1999, a pan-European project was started within the framework of the EU FAIR R&D programme. The study aims at initiating amendments to European legislation for food contact materials to establish and implement active and intelligent systems within the current relevant regulations for packaged food in Europe.1, 2 In 2000, a comprehensive report on legislative aspects of active and intelligent food packaging was published by a project group under the Nordic Council of Ministers. The report describes some types of active and intelligent food contact materials, the legislation the project group found to be relevant to consider, as well as some conclusions and proposals for administrators for future work with recommendations and interpretations of existing legislation. Also, the possibility of establishing new specific legislation for active and intelligent packaging is considered.3 Both initiatives will now be discussed in more detail below. 460 Novel food packaging techniques
Legislative issues relating to active and intelligent packaging 461 22.2 Initiatives to amend eu legislation: European project In 1999, a European study was started to enable the safe application of active and intelligent packaging systems throughout Europe by initiating amendments to European legislation for food contact materials in order to establish and implement these systems in current relevant regulations for packaged food in Europe. The study was entitled 'Evaluating safety, effectiveness, economic- environmental impact and consumer acceptance of active and intelligent packagings('Actipak). The Actipak project was co-ordinated by TNO Nutrition and Food Research and was jointly carried out by nine research organizations and three industrial companies. The research project consisted of five key tasks. The study was completed by the end of 2001. For each task the main results and conclusions are summarized below Task 1: Inventory At the start of the project an overview of all existing commercial and promising but not (yet) commercially available active and intelligent packaging systems was prepared. The review contains information on technology, market trends consumer needs and current legislation in Europe and relevant countries outside Europe. Part of the review has been described in detail in a separate publication. The main conclusion to be drawn from the review is that no European regulation currently covers the use of active and intelligent packaging The traditional European regulations for food contact materials, the overall migration limit and lists of approved compounds may be inconsistent with some of the objectives of active and intelligent packaging. In addition, some 25 packaging systems were selected for compositional analysis and overall migration study (Task 2) Task 2: Classification of active and intelligent systems In this task the composition and migration behaviour of selected active and intelligent packaging systems were investigated to identify conflicts with current legislation. A total of 20 active systems and 6 intelligent systems were investigated. The composition was investigated in view of the eu positive list and positive lists of national regulations. Determination of the composition focused on active ingredients and relevant reaction products. The compositional analysis of some active packaging systems has been described in detail.,SSome pical results are shown in Table 22. 1. The compositional analysis revealed that many active and intelligent packaging systems are very complex in composition. Apart from plastics, other materials such as paper, metals, adhesives, printing and minerals are being used. Existing EL legislation for food contact materials such as the EU Directive for polymeric food contact materials(Directive 90/128/EEC and its amendments)applies to only a minority of the materials tested. In addition, the overall migration behaviour of the active and intelligent packaging systems was investigated. Some relevant results of the overall migration study obtained for oxygen scavengers and moisture absorbers
22.2 Initiatives to amend EU legislation: European project In 1999, a European study was started to enable the safe application of active and intelligent packaging systems throughout Europe by initiating amendments to European legislation for food contact materials in order to establish and implement these systems in current relevant regulations for packaged food in Europe. The study was entitled ‘Evaluating safety, effectiveness, economicenvironmental impact and consumer acceptance of active and intelligent packagings’ (‘Actipak’). The Actipak project was co-ordinated by TNO Nutrition and Food Research and was jointly carried out by nine research organizations and three industrial companies.1 The research project consisted of five key tasks. The study was completed by the end of 2001. For each task the main results and conclusions are summarized below. Task 1: Inventory At the start of the project an overview of all existing commercial and promising but not (yet) commercially available active and intelligent packaging systems was prepared. The review contains information on technology, market trends, consumer needs and current legislation in Europe and relevant countries outside Europe. Part of the review has been described in detail in a separate publication.2 The main conclusion to be drawn from the review is that no European regulation currently covers the use of active and intelligent packaging. The traditional European regulations for food contact materials, the overall migration limit and lists of approved compounds may be inconsistent with some of the objectives of active and intelligent packaging. In addition, some 25 packaging systems were selected for compositional analysis and overall migration study (Task 2). Task 2: Classification of active and intelligent systems In this task the composition and migration behaviour of selected active and intelligent packaging systems were investigated to identify conflicts with current legislation. A total of 20 active systems and 6 intelligent systems were investigated. The composition was investigated in view of the EU positive list and positive lists of national regulations. Determination of the composition focused on active ingredients and relevant reaction products. The compositional analysis of some active packaging systems has been described in detail.4, 5 Some typical results are shown in Table 22.1.1 The compositional analysis revealed that many active and intelligent packaging systems are very complex in composition. Apart from plastics, other materials such as paper, metals, adhesives, printing and minerals are being used. Existing EU legislation for food contact materials such as the EU Directive for polymeric food contact materials (Directive 90/128/EEC and its amendments) applies to only a minority of the materials tested. In addition, the overall migration behaviour of the active and intelligent packaging systems was investigated. Some relevant results of the overall migration study obtained for oxygen scavengers and moisture absorbers Legislative issues relating to active and intelligent packaging 461
462 Novel food packaging techniques Table 22.1 Composition of some active and intelligent packaging systems Packaging system Ingredients identified Oxygen scavengers Polymeric scavenger Elements: Fe, Si, Ca, Al, Na, Cl, K, Mg, S, Mn, Ti, Co, Antimicrobial releasers Ethano Elements: Si, Na, Al, S, Cl, Ca, Mg, Fe, Pd, Ti Methylene blue and other colour indicators Mineral oil Elements: Na, Ca, K, Si, Al, Mg are presented in Table 22. 2. A complete overview of all migration values obtained in this study has been reported by De meulenaer et al. Quite a few migration values obtained exceed the overall migration limit. Some of the high levels observed were supposed to be attributable to the use of inappropriate liquid migration simulants. Solid migration simulants such as agar gels could be an lternative. The three time-temperature indicators were not included in the overal migration study. As the current systems are generally applied on the outside of the packaging and for relatively short periods of time, the packaging material can be considered to be a functional barrier, and therefore migration testing of time- temperature indicators is not relevant Based on the results of the evaluation of the composition and the migration behaviour, the active and intelligent systems were classified in view of restrictions of current regulations into five categories(A-E) according to the scheme shown in Fig. 22.1. These categories are Category A: Systems that comply with the current legislation (i.e. composition and migration) Category B: A system belongs to category B if it contains components not listed in the positive lists of the EC (90/128/EEC and amendments) but which are food additives and/or natural components and/or other components of which toxicological data are available. The migration behaviour of the category-B systems is in compliance with the migration limits as set by the eC
are presented in Table 22.2.1 A complete overview of all migration values obtained in this study has been reported by De Meulenaer et al. 5 Quite a few migration values obtained exceed the overall migration limit. Some of the high levels observed were supposed to be attributable to the use of inappropriate liquid migration simulants. Solid migration simulants such as agar gels could be an alternative.6 The three time-temperature indicators were not included in the overall migration study. As the current systems are generally applied on the outside of the packaging and for relatively short periods of time, the packaging material can be considered to be a functional barrier, and therefore migration testing of timetemperature indicators is not relevant. Based on the results of the evaluation of the composition and the migration behaviour, the active and intelligent systems were classified in view of restrictions of current regulations into five categories (A–E) according to the scheme shown in Fig. 22.1. These categories are: Category A: Systems that comply with the current legislation (i.e. composition and migration). Category B: A system belongs to category B if it contains components not listed in the positive lists of the EC (90/128/EEC and amendments) but which are food additives and/or natural components and/or other components of which toxicological data are available. The migration behaviour of the category-B systems is in compliance with the migration limits as set by the EC. Table 22.1 Composition of some active and intelligent packaging systems1 Packaging system Ingredients identified Oxygen scavengers Iron powder Silicates Sulfite Chloride Polymeric scavenger Elements: Fe, Si, Ca, Al, Na, Cl, K, Mg, S, Mn, Ti, Co, V, Cr, P Antimicrobial releasers Acids Silicates Ethanol Zinc Elements: Si, Na, Al, S, Cl, Ca, Mg, Fe, Pd, Ti Methylene blue and other colour indicators Indicators Acids Antioxidants Mineral oil Sugars Elements: Na, Ca, K, Si, Al, Mg 462 Novel food packaging techniques
Table 22.2 Overall migration from oxygen scavengers and moisture absorbers Overall migration(mg/sample)into Sample Wate 10% Olive Oxygen scavenger Sachet l0 days at40°C 800 2 days at20°C Oxygen scavenger Cap 10 days at 40C 2 days at 20C Oxygen scavenger Crown 1.54 +10 days at 40%C Moisture absorber Sachet 10 days at 40C <0.12 2 days at20°C <0.1a Moisture absorber Pad 10 days at 40C 2 days at20° Moisture absorber film 0 days at 40C 300 2 days at20° 5%(n=3or4) 5% and <10%(n=3 or 4) d Overall migration in mg/dm2 instead of mg/sample
Table 22.2 Overall migration from oxygen scavengers and moisture absorbers1 Overall migration (mg/sample) into: Sample Type Test Water 3% 10% 15% 95% Iso- Olive condition Acetic Ethanol Ethanol Ethanol octane oil acid Oxygen scavenger Sachet 10 days at 40ºC 620b 1700c – 800a 210c – 2 days at 20ºC 1.9c Oxygen scavenger Cap 10 days at 40ºC 74c 98c 80c – 43c – 2 days at 20C 0.9c Oxygen scavenger Crown 30 min. at 70ºC 1.0c 1.7c 1.5a – – – 27.8a + 10 days at 40ºC Moisture absorber Sachet 10 days at 40ºC 5% and 10% (n = 3 or 4) d Overall migration in mg/dm2 instead of mg/sample – Not measured
464 Novel food packaging gulations omponents Food additive positive lsts? Fig. 22.1 Classification of active and intelligent food-packaging systems in view of current legislation. For a description of categories A-E, see the text(reproduced with permissionfromFoodAdditivesandContaminantsJuly2002.http:/www.tandf.co.uk) Category C: These systems contain components that are included in the positive lists of the EC, but the migration exceeds the migration limit(s) set in the current legislation Category D: These systems contain components that are not included in the positive lists of the EC but are food additives or natural omponents or other components for which toxicological data are
Category C: These systems contain components that are included in the positive lists of the EC, but the migration exceeds the migration limit(s) set in the current legislation. Category D: These systems contain components that are not included in the positive lists of the EC but are food additives or natural components or other components for which toxicological data are Fig. 22.1 Classification of active and intelligent food-packaging systems in view of current legislation. For a description of categories A–E, see the text (reproduced with permission from Food Additives and Contaminants, July 2002. http:/www.tandf.co.uk). 464 Novel food packaging techniques
Legislative issues relating to active and intelligent packaging 465 available. In addition, the migration from the systems exceeds the migration limit(s)set by the EC Category E: These systems contain components that neither are listed nor are food additives or natural components or other components for which no toxicological data are available Most of the systems investigated could be classified into categories A and B Some fall into categories C and D. Only a carbon dioxide-releasing system could not be classified. Generally, it could be concluded that an extension of existing regulations with dedicated requirements seems to be necessary rmit the breakthrough of these materials on the Eu market and to guarantee their safe introduction and use in Europe. The results of the classification have been used to select representative combinations of foods and active and intelligent packaging systems for further validation studies An overview of the food-packaging combinations selected for evaluation of microbiological safety, shelf-life-extending capacity and efficacy of the active and intelligent systems is presented in Table 22.3 Task 3: Evaluation of microbiological safety, shelf-life-extending capacity and efficacy of active and intelligent systems In this task an overall evaluation of the capability (including effectiveness, safety and shelf-life-extending capacity)of the active and intelligent packaging systems was conducted. To this end, the microbiological safety of the test food, packed and stored in active packaging systems, was determined by analyzing their microbiological condition. In addition, the risk of false indication of ntelligent systems was examined. Furthermore, the effectiveness of active Table 22.3 Food-packaging combinations selected for validation studies Packaging system Food Oxygen-scavenging film Fresh pasta Moisture-absorbing p Fresh meat Ethylene-absorbing film Antimicrobial film Cheese Antimicrobial film Meat Antimicrobial film Aldehyde-absorbing film Milk powder Milk powd Antimicrobial sache Sandwich bread Oxygen-scavenging crown Oxygen indicators mea Sliced meat
available. In addition, the migration from the systems exceeds the migration limit(s) set by the EC. Category E: These systems contain components that neither are listed nor are food additives or natural components or other components for which no toxicological data are available. Most of the systems investigated could be classified into categories A and B. Some fall into categories C and D. Only a carbon dioxide-releasing system could not be classified.5 Generally, it could be concluded that an extension of existing regulations with dedicated requirements seems to be necessary to permit the breakthrough of these materials on the EU market and to guarantee their safe introduction and use in Europe. The results of the classification have been used to select representative combinations of foods and active and intelligent packaging systems for further validation studies. An overview of the food-packaging combinations selected for evaluation of microbiological safety, shelf-life-extending capacity and efficacy of the active and intelligent systems is presented in Table 22.3. Task 3: Evaluation of microbiological safety, shelf-life-extending capacity and efficacy of active and intelligent systems In this task an overall evaluation of the capability (including effectiveness, safety and shelf-life-extending capacity) of the active and intelligent packaging systems was conducted. To this end, the microbiological safety of the test food, packed and stored in active packaging systems, was determined by analyzing their microbiological condition. In addition, the risk of false indication of intelligent systems was examined. Furthermore, the effectiveness of active Table 22.3 Food-packaging combinations selected for validation studies Packaging system Food Oxygen-scavenging film Fresh pasta Moisture-absorbing film Fish Moisture-absorbing pad Fresh meat Ethylene-absorbing film Bananas Antimicrobial film Cheese Antimicrobial film Meat Antimicrobial film Fruit Aldehyde-absorbing film Cereal Oxygen-scavenging sachet Milk powder Oxygen-scavenging sachet Biscuits Moisture-absorbing sachet Milk powder Antimicrobial sachet Sandwich bread Oxygen-scavenging crown Beer Time-temperature indicators Fish Oxygen indicators Sliced meat Carbon dioxide indicator Sliced meat Legislative issues relating to active and intelligent packaging 465
466 Novel food packaging Table 22.4 Effectiveness and shel extending capacity of some food/active packaging test combinations Active packaging Food Effective Shelf-life extension Oxygen-scavenging Fresh pasta Yes Yes, longer microbiological shelf-life Moisture-absorbing Pork microbiological shelf-life Antimicrobial film Cheese/ No same microbiological shelf-life bread absorbing Cereals Y Yes, longer sensory and chemical shelf- No, but a good alternative(same sensory and chemical shelf-life)to MAP can packaging O2-absorbing sachet Cooked Yes, longer shelf-life/same microbiological shelf-life O2-absorbing crown Beer Yes lo. same sensorial shelf-life 4 Compared with a food/packaging combination without an active packaging system packaging systems to improve the microbiological stability of food, as compared to traditional packaging systems, was tested. Also the extension of sensory and chemical shelf-life was investigated for different active packaging/food combinations In total, 12 studies were performed to investigate the effectiveness and shelf-life-extending capacity of selected food/active packaging combinations Some typical results are presented in Table 22.4. Most of the active systems investigated appeared to be effective as claimed by their manufacturers. From the shelf-life studies it can be concluded that a number of active ndeed prolong shelf-life. The indication capacity of three time-temperature indicators, two oxygen indicators and a carbon dioxide indicator was investigated. The indicators investigated indicated relatively well the conditions they were meant for(time-temperature history, package headspace oxygen or carbon dioxide) Task 4: Toxicological, economic and environmental evaluation of active and ntelligent systems Intelligent devices and some active systems may contain substances that are not food additives and have not been evaluated by the EU Scientific Committee on Food(SCF) for use in food contact materials. Within the Actipak project it was therefore agreed to study the consequences when a substance is not on the positive list of the directives on food contact materials and to collect and interpret available toxicological data. Examination of existing toxicity data of
packaging systems to improve the microbiological stability of food, as compared to traditional packaging systems, was tested. Also the extension of sensory and chemical shelf-life was investigated for different active packaging/food combinations. In total, 12 studies were performed to investigate the effectiveness and shelf-life-extending capacity of selected food/active packaging combinations. Some typical results are presented in Table 22.4. Most of the active systems investigated appeared to be effective as claimed by their manufacturers. From the shelf-life studies it can be concluded that a number of active systems indeed prolong shelf-life. The indication capacity of three time-temperature indicators, two oxygen indicators and a carbon dioxide indicator was investigated. The indicators investigated indicated relatively well the conditions they were meant for (time-temperature history, package headspace oxygen or carbon dioxide). Task 4: Toxicological, economic and environmental evaluation of active and intelligent systems Intelligent devices and some active systems may contain substances that are not food additives and have not been evaluated by the EU Scientific Committee on Food (SCF) for use in food contact materials. Within the Actipak project it was therefore agreed to study the consequences when a substance is not on the positive list of the directives on food contact materials and to collect and interpret available toxicological data. Examination of existing toxicity data of Table 22.4 Effectiveness and shelf-life extending capacity of some food/active packaging test combinations Active packaging Food product Effective Shelf-life extension * Oxygen-scavenging film Fresh pasta Yes Yes, longer microbiological shelf-life not due to O2 absorption but to barrier characteristics of the active film Moisture-absorbing pad Pork Yes No, same microbiological and sensory shelf-life Antimicrobial film Cheese/ bread Possibly No, same microbiological shelf-life Aldehyde-absorbing film Cereals Yes Yes, longer sensory and chemical shelflife O2-absorbing sachet Milk powder Yes No, but a good alternative (same sensory and chemical shelf-life) to MAP can packaging O2-absorbing sachet Cooked ham Yes Yes, longer sensory shelf-life/same microbiological shelf-life O2-absorbing crown cork Beer Yes No, same sensorial shelf-life * Compared with a food/packaging combination without an active packaging system. 466 Novel food packaging techniques
Legislative issues relating to active and intelligent packaging 467 one substance with oxygen absorption capacity indicated the substance to be potentially mutagenic. This demonstrates that substances used in active and intelligent packaging systems should be evaluated by SCf before allowing them to come in contact with foodstuffs. In other words, they should be evaluated like all other substances used in food contact materials To establish acceptance among European consumers of active and intelligent systems that have been proved to be suitable and safe, these systems were subjected to an international study on consumers attitudes towards application of these systems. This study also provides insights into national differences and general attitudes. Consumer focus groups consisting of 8-12 people of mixed age and sex were formed in six European countries, namely the UK, Italy, Germany, the Netherlands, Finland and Spain. The results demonstrated that for active and intelligent devices to be readily accepted in Europe in the immediate future, their introduction to the marketplace should be supported by a substantial information campaign clarifying their benefits and how they function. They will not gain acceptance purely by virtue of extension of shelf-life. Also, to avoid confusion, some standardization, at least of indicators, would be preferable Attitudes are fairly consistent in Europe with the exception of Spain and possibly Italy. Consumers in Spain were much more ready to accept both active devices(absorbers, including sachets) and indicators, and responded very positively to them. Italy also seemed slightly keener than the rest of Europe The economic consequences and environmental implications of active and intelligent systems were evaluated as part of the project. The shelf-life extending capacity of active packaging is expected to reduce food waste due to spoilage. Consequently, energy and packaging materials may be saved. Multi- layer barrier packaging materials might be replaced by less complicated packaging materials, thus reducing packaging waste. In addition, from the study the conclusion can be drawn that the use of intelligent packaging such as time temperature indicators will decrease the waste generated in the long term Task 5: Recommendations for legislative amendments Finally, all results of the project and the requirements of all relevant EU regulations were evaluated. Based on this evaluation recommendations were drafted for the implementation of suitable active and intelligent systems in relevant European Directives. These recommendations were discussed informally with several national and European authorities. In addition to food kaging regulations, other relevant European regulations were studied such as regulations for food additives, biocides, pesticides, modified-atmosphere packaging, flavouring, food hygiene, labelling, product safety and packaging waste. These regulations generally do not form a serious hurdle to the safe introduction of active and intelligent food packaging systems in Europe. The directive on food hygiene even appeared to be an incentive to the use of active and intelligent packaging The first proposal for changing the framework Directive 89/109/EEC has resulted in a draft amendment of the this directive in which active packaging is
one substance with oxygen absorption capacity indicated the substance to be potentially mutagenic. This demonstrates that substances used in active and intelligent packaging systems should be evaluated by SCF before allowing them to come in contact with foodstuffs. In other words, they should be evaluated like all other substances used in food contact materials. To establish acceptance among European consumers of active and intelligent systems that have been proved to be suitable and safe, these systems were subjected to an international study on consumers’ attitudes towards application of these systems. This study also provides insights into national differences and general attitudes. Consumer focus groups consisting of 8–12 people of mixed age and sex were formed in six European countries, namely the UK, Italy, Germany, the Netherlands, Finland and Spain. The results demonstrated that for active and intelligent devices to be readily accepted in Europe in the immediate future, their introduction to the marketplace should be supported by a substantial information campaign clarifying their benefits and how they function. They will not gain acceptance purely by virtue of extension of shelf-life. Also, to avoid confusion, some standardization, at least of indicators, would be preferable. Attitudes are fairly consistent in Europe with the exception of Spain and possibly Italy. Consumers in Spain were much more ready to accept both active devices (absorbers, including sachets) and indicators, and responded very positively to them. Italy also seemed slightly keener than the rest of Europe. The economic consequences and environmental implications of active and intelligent systems were evaluated as part of the project. The shelf-lifeextending capacity of active packaging is expected to reduce food waste due to spoilage. Consequently, energy and packaging materials may be saved. Multilayer barrier packaging materials might be replaced by less complicated packaging materials, thus reducing packaging waste. In addition, from the study the conclusion can be drawn that the use of intelligent packaging such as timetemperature indicators will decrease the waste generated in the long term. Task 5: Recommendations for legislative amendments Finally, all results of the project and the requirements of all relevant EU regulations were evaluated. Based on this evaluation recommendations were drafted for the implementation of suitable active and intelligent systems in relevant European Directives. These recommendations were discussed informally with several national and European authorities. In addition to food packaging regulations, other relevant European regulations were studied such as regulations for food additives, biocides, pesticides, modified-atmosphere packaging, flavouring, food hygiene, labelling, product safety and packaging waste. These regulations generally do not form a serious hurdle to the safe introduction of active and intelligent food packaging systems in Europe. The directive on food hygiene even appeared to be an incentive to the use of active and intelligent packaging. The first proposal for changing the framework Directive 89/109/EEC has resulted in a draft amendment of the this directive in which active packaging is Legislative issues relating to active and intelligent packaging 467
468 Novel food packaging techniques included in the scope as described in Article 1. It is expected that this amendment will be approved by the end of 2003. This will remove the first barrier to the introduction of active packaging systems in Europe. A more detailed description of the results of this task will be given in section 22. 4 22.3 Initiatives to amend Eu legislation: Nordic report The Nordic countries(Denmark, Finland, Iceland, Norway and Sweden) have a long tradition of co-operation in the food packaging area, and these countries have similar legislation for food contact materials. A project group under the Nordic Council of Ministers has discussed the legal aspects of active and intelligent systems. The project group was chaired by Dr Fabech of the Danish Veterinary and Food Administration. In 2000, the project group published a report on legislative aspects of active and intelligent food packaging. This so- called "Nordic Report aimed at contributing to a solution of legislative problems related to active and intelligent food contact materials. In the first chapter of that report an overview is given of different types of active and intelligent food packaging. The effectiveness of these systems and the test requirements are discussed. The most important part of the report is a comprehensive overview of European legislation relevant to active and intelligent packaging. In section 22.4, a description of these Eu directives given and their relevance to active and intelligent packaging is discussed In the Nordic report recommendations are also given as to which parts of the EU legislation should be reviewed and which questions could be solved through interpretation of existing legislation. Preferably, harmonized legislation should be interpreted on a European basis to avoid divergence in interpretation, which could lead to barriers to trade. Proposals are given for solutions to problems by nterpretation. According to the Nordic group, it is not necessary to introduce new EU legislation. Instead, amendments should be made to existing legislation and guidelines on how to interpret existing legislation should be given. Finally initiatives are proposed to be taken by legislators, both on a national and on an EU level, when drafting new or revising existing legislation on active and intelligent packaging 22.4 Current EU legislation and recommendations for change For this study of relevant European regulations, a schedule was made of the scope of active and intelligent packaging systems. Definitions of active and ntelligent systems are proposed. Based on that principle an overview of the physical appearance of the systems is required as well as a division by functionality of the various systems
included in the scope as described in Article 1. It is expected that this amendment will be approved by the end of 2003. This will remove the first barrier to the introduction of active packaging systems in Europe. A more detailed description of the results of this task will be given in section 22.4. 22.3 Initiatives to amend EU legislation: Nordic report The Nordic countries (Denmark, Finland, Iceland, Norway and Sweden) have a long tradition of co-operation in the food packaging area, and these countries have similar legislation for food contact materials. A project group under the Nordic Council of Ministers has discussed the legal aspects of active and intelligent systems. The project group was chaired by Dr Fabech of the Danish Veterinary and Food Administration. In 2000, the project group published a report on legislative aspects of active and intelligent food packaging. 3 This socalled ‘Nordic Report’ aimed at contributing to a solution of legislative problems related to active and intelligent food contact materials. In the first chapter of that report an overview is given of different types of active and intelligent food packaging. The effectiveness of these systems and the test requirements are discussed. The most important part of the report is a comprehensive overview of European legislation relevant to active and intelligent packaging. In section 22.4, a description of these EU directives is given and their relevance to active and intelligent packaging is discussed. In the Nordic report recommendations are also given as to which parts of the EU legislation should be reviewed and which questions could be solved through interpretation of existing legislation. Preferably, harmonized legislation should be interpreted on a European basis to avoid divergence in interpretation, which could lead to barriers to trade. Proposals are given for solutions to problems by interpretation. According to the Nordic group, it is not necessary to introduce new EU legislation. Instead, amendments should be made to existing legislation and guidelines on how to interpret existing legislation should be given. Finally, initiatives are proposed to be taken by legislators, both on a national and on an EU level, when drafting new or revising existing legislation on active and intelligent packaging. 22.4 Current EU legislation and recommendations for change For this study of relevant European regulations, a schedule was made of the scope of active and intelligent packaging systems. Definitions of active and intelligent systems are proposed. Based on that principle an overview of the physical appearance of the systems is required as well as a division by functionality of the various systems. 468 Novel food packaging techniques