Legislative issues relating to active and intelligent packaging 469 2.4.1 Scope of active and intelligent systems Active svstems Active packaging systems may differ in appearance. Active packaging systems may be packaging materials to wrap foodstuffs, but may also be added to the packed food in the form of a sachet, label, box, etc. A correct description, which will be used in regulatory amendments, would be 'active food contact material systems'. For practical reasons, the term active packaging systems will be used Conventional packaging materials are considered passive, and their main function is protection against the environment. Active packaging systems intentionally absorb or release substances from or to the food or its environment Ingredients required to achieve the effect may be incorporated in the packaging material itself or packed in a sachet or label inserted into the package. The total contact area of active packaging systems may be the same as for conventional ackaging material, such as a film. but, in case of sachets or labels, the ratio may be significantly smaller than 6 dm"/kg food. This may influence migration requirements and testing protocols. Both absorption and release of substances should not endanger human health. For this purpose many regulations at the eu and the national level are in force, which should be taken into account to judge the acceptability of an active packaging system Intelligent systems Intelligent systems are only occasionally packaging materials. They usually are packed together, inside or outside the primary packaging, with the food in the form of a label, a pill, etc. As there is potential contact with food they should be called 'intelligent food contact material systems but, for practical reasons they will be called" intelligent packaging systems'here ntelligent packaging systems provide the user with information on the conditions of the food. Intelligent systems do not influence the food but provide information to consumers, retailers, manufacturers, etc. Intelligent packaging systems should not release their constituents to the food. In many cases a se called functional barrier, which prevents migration, is present. However, attention must be paid to the fact that intelligent systems may contain all kinds of chemicals required for detection of the intended information. Attention should also be paid to the acceptance of the use of these substances, particularly for packed foods presented directly to the consumer. Starting from the requirement that safety of the food and subsequently safety of the consumer shall never be endangered, the legal restrictions as well as the possibilities for the use of active and intelligent systems were studied in depth. Solutions for existing barriers are proposed 22. 4.2 Identification of relevant regulations Active and intelligent packaging systems in contact with foods should comply with regulations on food contact materials. In addition, the composition of the
22.4.1 Scope of active and intelligent systems Active systems Active packaging systems may differ in appearance. Active packaging systems may be packaging materials to wrap foodstuffs, but may also be added to the packed food in the form of a sachet, label, box, etc. A correct description, which will be used in regulatory amendments, would be ‘active food contact material systems’. For practical reasons, the term ‘active packaging systems’ will be used here. Conventional packaging materials are considered passive, and their main function is protection against the environment. Active packaging systems intentionally absorb or release substances from or to the food or its environment. Ingredients required to achieve the effect may be incorporated in the packaging material itself or packed in a sachet or label inserted into the package. The total contact area of active packaging systems may be the same as for conventional packaging material, such as a film. But, in case of sachets or labels, the ratio may be significantly smaller than 6 dm2 /kg food. This may influence migration requirements and testing protocols. Both absorption and release of substances should not endanger human health. For this purpose many regulations at the EU and the national level are in force, which should be taken into account to judge the acceptability of an active packaging system. Intelligent systems Intelligent systems are only occasionally packaging materials. They usually are packed together, inside or outside the primary packaging, with the food in the form of a label, a pill, etc. As there is potential contact with food they should be called ‘intelligent food contact material systems’ but, for practical reasons they will be called ‘intelligent packaging systems’ here. Intelligent packaging systems provide the user with information on the conditions of the food. Intelligent systems do not influence the food but provide information to consumers, retailers, manufacturers, etc. Intelligent packaging systems should not release their constituents to the food. In many cases a socalled functional barrier, which prevents migration, is present. However, attention must be paid to the fact that intelligent systems may contain all kinds of chemicals required for detection of the intended information. Attention should also be paid to the acceptance of the use of these substances, particularly for packed foods presented directly to the consumer. Starting from the requirement that safety of the food and subsequently safety of the consumer shall never be endangered, the legal restrictions as well as the possibilities for the use of active and intelligent systems were studied in depth. Solutions for existing barriers are proposed. 22.4.2 Identification of relevant regulations Active and intelligent packaging systems in contact with foods should comply with regulations on food contact materials. In addition, the composition of the Legislative issues relating to active and intelligent packaging 469
470 Novel food packaging techniques food can be influenced by the use of active packaging systems. The following regulations are considered and further discussed food contact material food additives flavouring hygiene product safety weight and volume 22.5 Food contact materials The requirements for food contact materials(FCM) are formulated in general terms in Framework Directive 89/109/EEC, some materials are regulated in detail in specific directives. Directive 89/109/EEC is under revision and will be published in 2003 22.51 Framework Directive 89/109/EEC Directive 89/109/EEC specifies the definition of FCM and general requirements Article 2 requires production of FCM according to good manufacturing practice, while application of FCM shall not endanger human health or change the composition or sensory properties in an unacceptable way. Article 6 describes the requirements for labelling and a demonstration of compliance with pecific directives Relevance to active and intelligent packaging systems Undoubtedly, active and intelligent packaging systems are intended to come into contact with food, although some may be separated by a'functional barrier'from the food. Therefore, active and intelligent packaging systems fall within the scope of framework Directive 89/109/EEC. According to article 2 they shall not endanger human health, nor change the foods sensory characteristics. The latter requirement may be influenced by personal preferences and could be an issue of discussion. In addition, in further specific directives like 2002/72/EC an overall migration limit of 60 mg/kg food is established as a purity requirement. Active systems developed to release certain components most likely will not comply with this requirement. To provide clarity, the scope of Directive 89/109/EEC should be extended to allow intentional migration from food contact materials at levels exceeding 60
food can be influenced by the use of active packaging systems. The following regulations are considered and further discussed: • food contact materials • food additives • flavouring • hygiene • biocides • pesticides • labelling • product safety • weight and volume • waste. 22.5 Food contact materials The requirements for food contact materials (FCM) are formulated in general terms in Framework Directive 89/109/EEC;7 some materials are regulated in detail in specific directives. Directive 89/109/EEC is under revision and will be published in 2003. 22.5.1 Framework Directive 89/109/EEC Directive 89/109/EEC specifies the definition of FCM and general requirements. Article 2 requires production of FCM according to good manufacturing practice, while application of FCM shall not endanger human health or change the composition or sensory properties in an unacceptable way. Article 6 describes the requirements for labelling and a demonstration of compliance with specific directives. Relevance to active and intelligent packaging systems Undoubtedly, active and intelligent packaging systems are intended to come into contact with food, although some may be separated by a ‘functional barrier’ from the food. Therefore, active and intelligent packaging systems fall within the scope of framework Directive 89/109/EEC. According to article 2, they shall not endanger human health, nor change the food’s sensory characteristics. The latter requirement may be influenced by personal preferences and could be an issue of discussion. In addition, in further specific directives like 2002/72/EC8 an overall migration limit of 60 mg/kg food is established as a purity requirement. Active systems developed to release certain components most likely will not comply with this requirement. To provide clarity, the scope of Directive 89/109/EEC should be extended to allow intentional migration from food contact materials at levels exceeding 60 mg/kg. 470 Novel food packaging techniques
Legislative issues relating to active and intelligent packaging 471 Intentional migration of substances has an effect on the composition of the food. It should be emphasized that the released substances are subject to various relevant regulations pertaining to food ingredients, food additives, labelling, etc Intelligent packaging systems shall comply with Article 2, so no additional provisions in the framework directive are considered necessary. Specific measures may be required to regulate the chemicals used in the intelligent packaging systems, but this is a subject of specific directives Recommendations for extending Directive 89/109/EEC Based on the results of the Actipak project, amendment of Directive 89/109 has been proposed, and the proposals have been adopted for implementation. A revised Directive will include an extended scope that mentions the allowed use of active and intelligent food contact materials. Special attention will be given to releasing packaging systems. The food in contact with such systems shall comply with any relevant food or food additive regulation. The releasing active packaging systems will be limited to materials that release substances added for that purpose. This means that natural materials, for example wooden barrels for wine or whisky storage, are excluded from the definition of active food contact materials e. Proper labelling will also be required. This includes the conditions(time and temperature)in which the system can be brought into contact with the food and the food that may be in contact with a releasing system. As food additive regulations have to be obeyed the food packer should be informed about the amount of substance released from one object. Annex I of the Directive will be extended with active and intelligent systems. Annex I contains a list of materials, covered by specific measures. This means that in the future a specific directive will be drafted on active and intelligent packaging systems 22. 5.2 Directive 80/590/EEC9 Symbol for food contact materials In Directive 80/590/EEC the symbol to be used for food contact materials not already in contact with foodstuffs is introduced. The symbol shall be used according to the requirements of Directive 89/109/EEC. Alternatively, subjects may be accompanied with the words'suitable for food contact Relevance to active and intelligent packaging systems Both active and intelligent packaging systems will not be available to consumers, as they usually require special care before bringing them into contact with foodstuffs. The final user of the A&l systems has to be informed that the subject is suitable for food contact, and thus the systems have to be labelled accordingly. Options are to print the symbol on the system or, at the wholesale stage, to add documentation with this symbol or proper wording. In those cases where a system as such is available to consumers the system should also be labelled in accordance with the requirements of this directive
Intentional migration of substances has an effect on the composition of the food. It should be emphasized that the released substances are subject to various relevant regulations pertaining to food ingredients, food additives, labelling, etc. Intelligent packaging systems shall comply with Article 2, so no additional provisions in the framework directive are considered necessary. Specific measures may be required to regulate the chemicals used in the intelligent packaging systems, but this is a subject of specific directives. Recommendations for extending Directive 89/109/EEC Based on the results of the Actipak project, amendment of Directive 89/109 has been proposed, and the proposals have been adopted for implementation. A revised Directive will include an extended scope that mentions the allowed use of active and intelligent food contact materials. Special attention will be given to releasing packaging systems. The food in contact with such systems shall comply with any relevant food or food additive regulation. The releasing active packaging systems will be limited to materials that release substances added for that purpose. This means that natural materials, for example wooden barrels for wine or whisky storage, are excluded from the definition of active food contact materials. Proper labelling will also be required. This includes the conditions (time and temperature) in which the system can be brought into contact with the food and the food that may be in contact with a releasing system. As food additive regulations have to be obeyed the food packer should be informed about the amount of substance released from one object. Annex I of the Directive will be extended with active and intelligent systems. Annex I contains a list of materials, covered by specific measures. This means that in the future a specific directive will be drafted on active and intelligent packaging systems. 22.5.2 Directive 80/590/EEC9 Symbol for food contact materials In Directive 80/590/EEC the symbol to be used for food contact materials not already in contact with foodstuffs is introduced. The symbol shall be used according to the requirements of Directive 89/109/EEC. Alternatively, subjects may be accompanied with the words ‘suitable for food contact’. Relevance to active and intelligent packaging systems Both active and intelligent packaging systems will not be available to consumers, as they usually require special care before bringing them into contact with foodstuffs. The final user of the A&I systems has to be informed that the subject is suitable for food contact, and thus the systems have to be labelled accordingly. Options are to print the symbol on the system or, at the wholesale stage, to add documentation with this symbol or proper wording. In those cases where a system as such is available to consumers the system should also be labelled in accordance with the requirements of this directive. Legislative issues relating to active and intelligent packaging 471
472 Novel food packaging techniques Recommendations Directive 80/590/EEC should be followed. There is no need for amendment of 22.53 Plastics directives Directive 2002/72/EC sets requirements for food contact materials manufactured solely from plastics. The composition of plastics permitted as food contact materials is based on the principle of a positive list. Maximum allowed migration limits of plastic components are based on the toxicological properties of substances. An overall migration limit of 60 mg/kg food or 10 mg/dm is set to prevent contamination of the food to an unacceptable level The directive is intended to harmonize certain classes of substances such as monomers, starting materials and additives. Polymerization regulators are not covered by the directive, but they shall not endanger human health according to framework Directive 89/109/EEC. In some countries, including the netherlands and Germany, these substances are regulated at a national level. Article 8 of Directive 2002/72/EC requires verification of compliance with the requirements of the directive in accordance with the rules laid down in Directives 82/711/EEC and 85/572/EEC. In addition, the materials and articles shall be accompanied with a declaration of compliance at the marketing stage rather than the retail stage levance to active and intelligent packaging systems Active packaging systems manufactured solely from plastics must comply with the requirements of Directive 2002/72/EC, meaning that composition and migration behaviour must be in compliance with the positive list and the migration restrictions. Active packaging systems, such as some types of oxygen absorbers, based on active ingredients that are incorporated in the backbone of the polymer shall comply with the directive. It is argued that these materials may be used to wrap the food in the same way as conventional packaging materials This means that all substances used should have been evaluated by the SCF and be added to the positive list with or without a specific migration limit Plastic materials and articles containing a substance intentionally released the food should be treated differently. The base polymer should comply with Directive 2002/72/EC, whereas the released substance should be an approved rood ingredient or food additive. Listing of the released substances on the positive list for plastics seems unnecessary as these substances should be allowed as food ingredients or food additives. However. allowance of the presence of such substances should be provided for in the plastics directive Overall migration from releasing materials or articles may conflict with the overall migration limit. A requirement of enforcement authorities may be the possibility to check the overall migration of the polymer itself. In principle, this could be determined by the classic determination of the overall migration and subsequent subtraction of the specific migration of the released substance However, in many cases the amount of released substance may be much higher
Recommendations Directive 80/590/EEC should be followed. There is no need for amendment of this directive. 22.5.3 Plastics directives Directive 2002/72/EC sets requirements for food contact materials manufactured solely from plastics. The composition of plastics permitted as food contact materials is based on the principle of a positive list. Maximum allowed migration limits of plastic components are based on the toxicological properties of substances. An overall migration limit of 60 mg/kg food or 10 mg/dm2 is set to prevent contamination of the food to an unacceptable level. The directive is intended to harmonize certain classes of substances such as monomers, starting materials and additives. Polymerization regulators are not covered by the directive, but they shall not endanger human health according to framework Directive 89/109/EEC. In some countries, including the Netherlands and Germany, these substances are regulated at a national level. Article 8 of Directive 2002/72/EC requires verification of compliance with the requirements of the directive in accordance with the rules laid down in Directives 82/711/EEC and 85/572/EEC. In addition, the materials and articles shall be accompanied with a declaration of compliance at the marketing stage rather than the retail stage. Relevance to active and intelligent packaging systems Active packaging systems manufactured solely from plastics must comply with the requirements of Directive 2002/72/EC, meaning that composition and migration behaviour must be in compliance with the positive list and the migration restrictions. Active packaging systems, such as some types of oxygen absorbers, based on active ingredients that are incorporated in the backbone of the polymer shall comply with the directive. It is argued that these materials may be used to wrap the food in the same way as conventional packaging materials. This means that all substances used should have been evaluated by the SCF and be added to the positive list with or without a specific migration limit. Plastic materials and articles containing a substance intentionally released to the food should be treated differently. The base polymer should comply with Directive 2002/72/EC, whereas the released substance should be an approved food ingredient or food additive. Listing of the released substances on the positive list for plastics seems unnecessary as these substances should be allowed as food ingredients or food additives. However, allowance of the presence of such substances should be provided for in the plastics directive. Overall migration from releasing materials or articles may conflict with the overall migration limit. A requirement of enforcement authorities may be the possibility to check the overall migration of the polymer itself. In principle, this could be determined by the classic determination of the overall migration and subsequent subtraction of the specific migration of the released substance. However, in many cases the amount of released substance may be much higher 472 Novel food packaging techniques
Legislative issues relating to active and intelligent packaging 473 than the overall migration limit and the analytical error may be even higher than the overall migration limit itself. As a matter of fact, the plastic material can only be verified for compliance if the plastic is available without the releasing substance. This would require either enforcement of the plastic material at an early stage or demonstration of compliance by a reliable and acceptable certification procedure mogeneous intelligent systems manufactured from plastics only(mono- and multi-layers)and in which the intelligent ingredients are immobilized in the polymer backbone or blended as an additive in the plastic should comply with the requirements of Directive 2002/72/EC provided they are intended to come directly into contact with the food e two types of composed materials and articles can be identified. First, there systems that are manufactured by packing the active or intelligent ingredients in a plastic bag or box. Such a system is usually inserted into the primary package with the foodstuff. The plastic part of the system should be in compliance with Directive 2002/72/EC. However, the ingredients packed inside cannot be considered as plastic. These systems should be considered an entity of a food contact material and hence the whole system is excluded from the plastics regulation. Special provisions will be required to include this type of food contact materials Systems of a second type are composed of various types of packaging materials, such as plastic, paper, metal, printing, adhesives, varnish and active or intelligent ingredients. Usually the individual components of the final system are hard to recognize. Such composite materials and articles are not covered by Directive 2002/72/EC. It is most likely that no EU regulation exists on the individual parts of the system. Regulations for paper, metal, printing inks and varnishes exist at the national level of some member states, waiting for harmonization at the eu level. This means that these systems are subject to national regulations and to the framework Directive 89/109/EEC. Both fo enforcement authorities and for manufacturers this is an uncomfortable situation as it is difficult to establish the safety of these types of food contact materials. It seems realistic to assume that fully harmonized legislation on all types of food contact materials will not be available in the short term Concerning active and intelligent ingredients, it was found that some ar already included in a positive list, such as iron oxide used in oxygen absorbers but many others are not. However, all these substances need to be regulated to avoid their use is forbidden without firm grounds and the possibility that unsafe situations may occur. Therefore, if there is direct contact with the food, the system should be submitted to migration testing protocols and the relevant substances should be toxicologically evaluated and subsequently added to positive list. Frequently applied intelligent systems, such as time/temperature indicators, are positioned on the outside of the primary food packaging. In addition, these systems are usually made of plastic and connected to the packaging by an adhesive layer. Use of time/temperature indicators almost automatically implies
than the overall migration limit and the analytical error may be even higher than the overall migration limit itself. As a matter of fact, the plastic material can only be verified for compliance if the plastic is available without the releasing substance. This would require either enforcement of the plastic material at an early stage or demonstration of compliance by a reliable and acceptable certification procedure. Homogeneous intelligent systems manufactured from plastics only (monoand multi-layers) and in which the intelligent ingredients are immobilized in the polymer backbone or blended as an additive in the plastic should comply with the requirements of Directive 2002/72/EC provided they are intended to come directly into contact with the food. Two types of composed materials and articles can be identified. First, there are systems that are manufactured by packing the active or intelligent ingredients in a plastic bag or box. Such a system is usually inserted into the primary package with the foodstuff. The plastic part of the system should be in compliance with Directive 2002/72/EC. However, the ingredients packed inside cannot be considered as plastic. These systems should be considered an entity of a food contact material and hence the whole system is excluded from the plastics regulation. Special provisions will be required to include this type of food contact materials. Systems of a second type are composed of various types of packaging materials, such as plastic, paper, metal, printing, adhesives, varnish and active or intelligent ingredients. Usually the individual components of the final system are hard to recognize. Such composite materials and articles are not covered by Directive 2002/72/EC. It is most likely that no EU regulation exists on the individual parts of the system. Regulations for paper, metal, printing inks and varnishes exist at the national level of some member states, waiting for harmonization at the EU level. This means that these systems are subject to national regulations and to the framework Directive 89/109/EEC. Both for enforcement authorities and for manufacturers this is an uncomfortable situation as it is difficult to establish the safety of these types of food contact materials. It seems realistic to assume that fully harmonized legislation on all types of food contact materials will not be available in the short term. Concerning active and intelligent ingredients, it was found that some are already included in a positive list, such as iron oxide used in oxygen absorbers, but many others are not. However, all these substances need to be regulated to avoid their use is forbidden without firm grounds and the possibility that unsafe situations may occur. Therefore, if there is direct contact with the food, the system should be submitted to migration testing protocols and the relevant substances should be toxicologically evaluated and subsequently added to a positive list. Frequently applied intelligent systems, such as time/temperature indicators, are positioned on the outside of the primary food packaging. In addition, these systems are usually made of plastic and connected to the packaging by an adhesive layer. Use of time/temperature indicators almost automatically implies Legislative issues relating to active and intelligent packaging 473