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 <0.1a 970c – 0.6c 2.3c 2 days at 20ºC <0.1a – Moisture absorber Pad 10 days at 40ºC 9.3b 46c – 7.2b 21c – 2 days at 20ºC 18c Moisture absorberd Film 10 days at 40ºC 260a 300a – 300b 8.2b – 2 days at 20ºC 0.1c a Standard deviation <5% (n = 3 or 4) b Standard deviation >5% and <10% (n = 3 or 4) c Standard deviation > 10% (n = 3 or 4) d Overall migration in mg/dm2 instead of mg/sample – Not measured